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Trial record 9 of 56 for:    severe preeclampsia AND weeks of gestation

Restrictive Fluid Therapy in Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT02214186
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : September 7, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Pre-Eclampsia
Intervention Other: Restrictive Fluid Therapy
Enrollment 46
Recruitment Details  
Pre-assignment Details We calculated the total sample size from a pilot study. Assuming a power of 80% and 95% confidence, the sample necessary to conduct the study was 21 patients in each group of interest. As we considered 10% as maximum margin of loss during follow-up, there were 23 patients enrolled in each group.
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Period Title: Overall Study
Started 23 23
Completed 21 21
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             1             1
Protocol Violation             1             1
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy Total
Hide Arm/Group Description The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Total of all reporting groups
Overall Number of Baseline Participants 23 23 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 46 participants
31  (8) 33  (5) 32.07  (6.77)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
23
 100.0%
23
 100.0%
46
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Gestational age (weeks)  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 23 participants 23 participants 46 participants
36.9
(35.3 to 37.0)
36.7
(30.1 to 37.4)
36.8
(33 to 37.2)
Body mass index (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 23 participants 23 participants 46 participants
33.78  (7.17) 31.98  (5.58) 32.88  (6.37)
Twin pregnancy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
yes 2 3 5
no 21 20 38
Chronic hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
yes 11 9 20
no 12 14 26
Previous preeclampsia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
yes 9 11 20
no 14 12 26
Diabetes Mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
yes 9 5 14
no 14 18 32
Systolic blood pressure (mmHg)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 23 participants 23 participants 46 participants
161  (17) 170  (20) 165.5  (18.5)
Diastolic blood pressure (mmHg)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 23 participants 23 participants 46 participants
100.05  (11.75) 104.80  (15.75) 102.42  (13.75)
1.Primary Outcome
Title Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy
Hide Description Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.
Time Frame preoperative, first and second day postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Were included in the analysis the patients who violated the protocol and lost follow-up (intention to treat analysis)
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Creatinine preoperative
0.69
(0.55 to 0.83)
0.73
(0.55 to 0.83)
Creatinine 1st post-operative
0.99
(0.80 to 1.22)
0.93
(0.76 to 1.25)
Creatinine 2nd post-operative
0.96
(0.80 to 1.09)
0.84
(0.69 to 1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney followed by Friedman test
2.Primary Outcome
Title Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index
Hide Description Renal dysfunction was stratified by the Acute Kidney Injury Network (AKIN) index in three stages, in terms of creatinine increase from baseline: stage 1 included an interval of 150–200%, stage 2 200%–300%, and stage 3 more than 300% or hemodialysis
Time Frame Postoperative renal dysfunction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Measure Type: Number
Unit of Measure: participants
AKIN stage I 7 6
AKIN stage II 2 4
AKIN stage III 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia
Hide Description Evaluate new marker of renal injury (NGAL) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.
Time Frame preoperative, first and second day postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: mg/L
NGAL preoperative
0.16
(0.10 to 0.20)
0.15
(0.13 to 0.22)
NGAL 1st post-operative day
0.18
(0.13 to 026)
0.21
(0.16 to 0.29)
NGAL 2nd post-operative day
0.15
(0.10 to 0.24)
0.15
(0.11 to 0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney followed by Friedman test
4.Secondary Outcome
Title Cystatin C as New Marker of Renal Injury in Preeclampsia
Hide Description Evaluate new marker of renal injury (Cystatin C) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.
Time Frame preoperative, first and second day postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: mg/L
Cyst C preoperative 1.73  (0.6) 1.99  (0.61)
Cyst C 1st postoperative day 1.93  (0.8) 2.03  (0.66)
Cyst C 2nd postoperative day 1.64  (0.5) 1.72  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments ANOVA for repeated measures
5.Secondary Outcome
Title Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration
Hide Description Proteinuria in severe pre-eclampsia submitted to cesarean section under different regimes of hydration. Analyses in pre-operative and post-operative period.
Time Frame Proteinuria in severe pre-eclampsia in in pre-operative and post-operative period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: g/dl
Proteinuria pre-operative
0.46
(0.32 to 1.71)
2.62
(0.80 to 9.60)
Proteinuria 1st post-operative day
0.15
(0.10 to 0.88)
0.40
(0.28 to 0.58)
Proteinuria 2nd post-operative day
0.20
(0.10 to 0.48)
0.45
(0.10 to 2.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney followed by Friedman test
6.Secondary Outcome
Title Platelets in Restrictive Fluid Management of Severe Preeclampsia
Hide Description Compare platelets count in the restrictive and liberal groups during the first and second post-operative days.
Time Frame preoperative, first and second day postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: thrombocytes/mm3
Platelets preoperative 194400  (77867) 207941  (71371)
Platelets 1st postoperative day 183250  (83234) 201118  (61687)
Platelets 2nd postoperative day 192850  (80692) 221824  (62925)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments ANOVA for repeated measures.
7.Secondary Outcome
Title International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
Hide Description

Compare International Normalized Ratio (INR) of Prothrombin Time (PT) in the restrictive and liberal groups in preoperative, first and second day postoperative.

PT is expressed in seconds and the entered values represented the INR of PT among study participants and a control population.

Time Frame preoperative, first and second day postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
The values are expressed in seconds and presented as a ration (INR) with control patients.
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: ratio
PT/INR preoperative
1.00
(0.95 to 1.10)
0.95
(0.95 to 0.98)
PT/INR first post-operative day
1.03
(0.95 to 1.09)
0.95
(0.95 to 0.99)
PT/INR seconde post-operative day
1.0
(0.97 to 1.07)
0.95
(0.95 to 0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney followed by Friedman test
8.Secondary Outcome
Title Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
Hide Description

Compare activated partial thromboplastin time (APPT) and relation with control (R) in the restrictive and liberal groups.

APPT is a laboratory test that evaluates the efficiency of the intrinsic pathway of coagulation. The unit of measure is seconds and the results are presented as relation (R) with control.

Time Frame preoperative, first and second day postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
The values are expressed in seconds and presented as a ration (R) with control patients.
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ratio
APPT/R preoperative 0.98  (0.13) 1.01  (0.08)
APPT/R 1st post-operative day 1.07  (0.10) 1.03  (0.10)
APPT/R 2nd post-operative day 1.07  (0.13) 1.01  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments ANOVA for repeated measures.
9.Other Pre-specified Outcome
Title Urine Output During Cesarean Section in Severe Pre-eclampsia
Hide Description Urine output during cesarean section in severe pre-eclampsia under two different regimes of hydration (restrictive and liberal)
Time Frame urine output during cesarean section (an average of 60 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description:
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

Overall Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: ml/h
116
(69 to 191)
80
(37 to 110)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal Fluid Therapy, Restrictive Fluid Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Possible adverse event were observed during the first and second post-operative days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liberal Fluid Therapy Restrictive Fluid Therapy
Hide Arm/Group Description The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.

The restrictive group will receive 250 mL of crystalloid solution during cesarean section.

Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.

All-Cause Mortality
Liberal Fluid Therapy Restrictive Fluid Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liberal Fluid Therapy Restrictive Fluid Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liberal Fluid Therapy Restrictive Fluid Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M.D. Wallace Andrino da Silva
Organization: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Phone: +551126616787
EMail: wallaceandrino@yahoo.com.br
Publications:
Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02214186     History of Changes
Other Study ID Numbers: CAPPesq 675.011
First Submitted: July 16, 2014
First Posted: August 12, 2014
Results First Submitted: July 6, 2015
Results First Posted: September 7, 2015
Last Update Posted: March 7, 2017