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The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients

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ClinicalTrials.gov Identifier: NCT02841046
Recruitment Status : Completed
First Posted : July 21, 2016
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Lin Yang, First Affiliated Hospital, Sun Yat-Sen University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Fluid Therapy
Interventions Device: cardiac index
Device: Stroke Volume Variation
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group Cardiac Index Group Stroke Volume Variation
Hide Arm/Group Description

the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index(CI) as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .

cardiac index: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.

the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation(SVV)and cardiac index(CI)as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .

Stroke Volume Variation: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.

Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Group Cardiac Index Group Stroke Volume Variation Total
Hide Arm/Group Description

the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index(CI) as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .

cardiac index: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.

the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation(SVV)and cardiac index(CI)as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .

Stroke Volume Variation: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
40.9  (7.9) 39.7  (8.3) 40.3  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
10
  40.0%
8
  32.0%
18
  36.0%
Male
15
  60.0%
17
  68.0%
32
  64.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Number of Days Needed for Anal Exsufflation After Surgery
Hide Description record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group Cardiac Index Group Stroke Volume Variation
Hide Arm/Group Description:

the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index(CI) as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .

cardiac index: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.

the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation(SVV)and cardiac index(CI)as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .

Stroke Volume Variation: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: days
3.8  (1.1) 2.7  (1.2)
2.Secondary Outcome
Title the Incidence of Adverse Cardiovascular Events
Hide Description including hypertension,hypotension,tachycardia,bradycardia
Time Frame during the surgery
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Oxygen Delivery(DO2)
Hide Description oxygen delivery(DO2) in ml•min-1•m-2.Record the data of DO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
Time Frame during the surgery
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Oxygen Consumption(VO2)
Hide Description oxygen delivery(VO2) in ml•min-1•m-2.Record the data of VO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
Time Frame during the surgery
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Oxygen Extraction Rate(ERO2)
Hide Description oxygen extraction rate(ERO2) in percentage.Record the data of ERO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
Time Frame during the surgery
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Number of Days in Hospital
Hide Description The number of days from the admission to hospital until the discharge from hospital
Time Frame up to 10 weeks
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title The Volume of Crystalloid Infusion
Hide Description Volume of crystalloid infusion in milliliter.
Time Frame during the surgery
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title The Volume of Colloid Infusion
Hide Description Volume of colloid infusion in milliliter.
Time Frame during the surgery
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Complication After Surgery
Hide Description From the end of surgery to the time of discharge from hospital.including ileus,abdominal infection,infection of incisional wound,pulmonary infection
Time Frame up to 8 weeks
Outcome Measure Data Not Reported
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group Cardiac Index Group Stroke Volume Variation
Hide Arm/Group Description

the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index(CI) as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .

cardiac index: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.

the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation(SVV)and cardiac index(CI)as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .

Stroke Volume Variation: group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.

All-Cause Mortality
Group Cardiac Index Group Stroke Volume Variation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Group Cardiac Index Group Stroke Volume Variation
Affected / at Risk (%) Affected / at Risk (%)
Total   5/25 (20.00%)   1/25 (4.00%) 
Gastrointestinal disorders     
abdominal infection   4/25 (16.00%)  1/25 (4.00%) 
ileus   3/25 (12.00%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Group Cardiac Index Group Stroke Volume Variation
Affected / at Risk (%) Affected / at Risk (%)
Total   2/25 (8.00%)   1/25 (4.00%) 
Infections and infestations     
infection of incisional wound   2/25 (8.00%)  1/25 (4.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Dr. Yang Lin
Organization: Guangzhou Panyu central Hospital
Phone: +8615915721012
EMail: salinyangyl@163.com
Publications of Results:
Layout table for additonal information
Responsible Party: Lin Yang, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02841046    
Other Study ID Numbers: [2014]No.60
First Submitted: July 8, 2016
First Posted: July 21, 2016
Results First Submitted: February 18, 2020
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020