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Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach

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ClinicalTrials.gov Identifier: NCT02135146
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypotension
Kidney Injury
Interventions Drug: Plasmalyte 3ml/kg/hr group
Drug: Plasmalyte 6ml/kg/hr group
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group Total
Hide Arm/Group Description Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
62.2  (9.2) 65.1  (12.1) 63.6  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
16
  80.0%
19
  95.0%
35
  87.5%
Male
4
  20.0%
1
   5.0%
5
  12.5%
ASA Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
ASA 2
9
  45.0%
5
  25.0%
14
  35.0%
ASA 3
11
  55.0%
15
  75.0%
26
  65.0%
[1]
Measure Description:

The American Society of Anesthesiology (ASA) Physical Status Classification of the patient's present physical condition on a scale from 1-6 classifications are as follows: ASA 1. Normal healthy patient.

ASA 2. Patient with mild systemic disease. ASA 3. Patient with severe systemic disease. ASA 4. Patient with severe systemic disease that is a constant threat to life. ASA 5. Moribund patient who is not expected to survive without the operation. ASA 6. Declared brain-dead patient whose organs are being removed for donor purposes.

Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 20 participants 20 participants 40 participants
58.8  (10.9) 65.2  (12.1) 62.02  (11.9)
Ideal Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 20 participants 20 participants 40 participants
57.9  (8.5) 57.16  (5.5) 57.5  (7.1)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 20 participants 20 participants 40 participants
165.1  (7.9) 165  (5.9) 165.05  (6.8)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 20 participants 20 participants 40 participants
21.5  (3.2) 24.1  (4.9) 22.8  (4.3)
[1]
Measure Description: Body Mass Index (BMI) is weight in kilograms divided by the square of height in meters. Scores between 18.5 and 24.9 indicate healthy body weights. Higher scores indicate higher body weights.
Epidural  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
4
  20.0%
3
  15.0%
7
  17.5%
Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
9
  45.0%
9
  45.0%
18
  45.0%
Chronic Obstructive Pulmonary Disease (COPD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
5
  25.0%
0
   0.0%
5
  12.5%
Asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
3
  15.0%
2
  10.0%
5
  12.5%
Pulmonary Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
0
   0.0%
0
   0.0%
0
   0.0%
Coronary Artery Disease (CAD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
1
   5.0%
1
   5.0%
2
   5.0%
Hypertension (HTN)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
6
  30.0%
4
  20.0%
10
  25.0%
Heart Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
0
   0.0%
1
   5.0%
1
   2.5%
Peripheral Vascular Disease (PVD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
0
   0.0%
0
   0.0%
0
   0.0%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
3
  15.0%
0
   0.0%
3
   7.5%
Hepatitis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
3
  15.0%
0
   0.0%
3
   7.5%
Chronic Kidney Disease (CKD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
0
   0.0%
0
   0.0%
0
   0.0%
Seizure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
1
   5.0%
0
   0.0%
1
   2.5%
Lung Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
5
  25.0%
7
  35.0%
12
  30.0%
Chronic Lung Infection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
15
  75.0%
13
  65.0%
28
  70.0%
Surgical Procedure (Video-Assisted Thoracoscopic Surgery-VATS)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
18
  90.0%
19
  95.0%
37
  92.5%
Procedure Duration  
Mean (Standard Deviation)
Unit of measure:  Min
Number Analyzed 20 participants 20 participants 40 participants
162.1  (75.1) 153.4  (62.7) 157.8  (68.5)
Anesthesia Duration  
Mean (Standard Deviation)
Unit of measure:  Min
Number Analyzed 20 participants 20 participants 40 participants
206.6  (79.4) 198.9  (67.4) 202.7  (72.8)
Creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 20 participants 20 participants 40 participants
0.86  (0.22) 0.84  (0.17) 0.85  (0.195)
1.Primary Outcome
Title Development of Renal Injury
Hide Description

Acute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively (serum creatinine levels). The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI.

(1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase > two- to threefold from baseline. (3) Increase > threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L).

Time Frame Post-op up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description:
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.8  (0.25) 0.74  (0.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Plasmalyte 3ml/kg/hr Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Plasmalyte 6ml/kg/hr Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Development of Pulmonary Edema
Hide Description The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported.
Time Frame Post-op up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description:
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
4
  20.0%
3
  15.0%
3.Secondary Outcome
Title Length of Surgical Intensive Unit Stay/Hospital Stay
Hide Description Length of Surgical Intensive Unit Stay/Hospital Stay
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description:
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: days
0.6  (1.5) 0.2  (0.7)
4.Secondary Outcome
Title Removal of Chest Tubes
Hide Description Time to removal of Chest Tubes
Time Frame Post-op up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description:
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: minutes
3.5  (2.5) 3.7  (3.9)
5.Secondary Outcome
Title Development of Morbidity
Hide Description Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description:
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
4
  20.0%
5
  25.0%
6.Secondary Outcome
Title Death
Hide Description Death
Time Frame Assessed up to 30 days Post-op
Hide Outcome Measure Data
Hide Analysis Population Description
Missing participants lost to follow-up.
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description:
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Overall Number of Participants Analyzed 9 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Hide Arm/Group Description Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
All-Cause Mortality
Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      5/20 (25.00%)    
Cardiac disorders     
Atrial Fibrillation   0/20 (0.00%)  0 1/20 (5.00%)  1
Supraventricular tachycardia (SVT)   0/20 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Edema   4/20 (20.00%)  4 3/20 (15.00%)  3
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plasmalyte 3ml/kg/hr Group Plasmalyte 6ml/kg/hr Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nick Naughton, Professional Research Assistant
Organization: University of Colorado
Phone: 3037200833
EMail: nick.naughton@cuanschutz.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02135146    
Other Study ID Numbers: 13-1900
13-1900 ( Other Identifier: COMIRB )
First Submitted: May 6, 2014
First Posted: May 9, 2014
Results First Submitted: February 24, 2020
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020