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Trial record 6 of 52 for:    TIMP2

Fluid Chloride and AKI in Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT02668952
Recruitment Status : Completed
First Posted : January 29, 2016
Results First Posted : March 19, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Neal Gerstein, University of New Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Acute Kidney Injury
Interventions Drug: 0.9% Normal Saline (0.9% Sodium Chloride) injection
Drug: Isolyte S injection
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Period Title: Overall Study
Started 16 14
Completed 16 14
Not Completed 0 0
Arm/Group Title Normal Saline Group Isolyte Group Total
Hide Arm/Group Description

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
65.3  (11.0) 62.8  (9.4) 64.1  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
6
  37.5%
8
  57.1%
14
  46.7%
Male
10
  62.5%
6
  42.9%
16
  53.3%
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: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16
 100.0%
14
 100.0%
30
 100.0%
[TIMP2] x [IGFBP7]   [1] 
Mean (Standard Deviation)
Unit of measure:  (ng/mL)^2/1000
Number Analyzed 16 participants 14 participants 30 participants
0.101  (0.096) 0.116  (0.138) 0.108  (0.115)
[1]
Measure Description: This measure is an index consisting of the product of laboratory-derived serum concentrations of tissue inhibitor of metalloproteinase 2 and insulin-like growth factor binding protein 7.
Serum creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 16 participants 14 participants 30 participants
0.93  (0.18) 0.88  (0.14) 0.91  (0.16)
Serum chloride  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 16 participants 14 participants 30 participants
108  (3.1) 106  (3.4) 107  (3.2)
1.Primary Outcome
Title Change in [TIMP2]*[IGFBP7] Biomarker
Hide Description The difference in the [TIMP2]*[IGFBP7] biomarker between the preoperative value and a repeated measurement at 24 hours postoperatively. Positive values represent increase; negative values represent decrease
Time Frame Baseline and postoperatively at 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description:

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: (ng/mL)^2/1000
0.015  (0.125) 0.009  (0.148)
2.Secondary Outcome
Title Serum Creatinine Level at 24 Hours
Hide Description Serum creatinine measurement at 24 hours
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description:

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.85  (0.24) 0.80  (0.16)
3.Secondary Outcome
Title Serum Chloride Level at 24 Hours
Hide Description Serum chloride ion measurement at 24 hours postoperatively
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description:

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: mmol/L
110  (3.0) 106  (3.1)
4.Secondary Outcome
Title Proportion of Patients With Need for Dialysis
Hide Description Clinically-determined need for dialysis prior to discharge from hospital
Time Frame One week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description:

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Overall Number of Participants Analyzed 16 14
Measure Type: Number
Unit of Measure: percentage of patients
0 0
5.Secondary Outcome
Title Postoperative Arterial pH
Hide Description Arterial pH, measured 24 hours after surgery
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description:

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: pH
7.38  (0.03) 7.41  (0.05)
6.Secondary Outcome
Title Serum Creatinine Level at 48 Hours
Hide Description Serum creatinine level 48 hours postoperatively
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description:

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.91  (0.31) 0.74  (0.14)
7.Secondary Outcome
Title Serum Chloride at 48 Hours
Hide Description Serum chloride measurement at 48 hours postoperatively
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description:

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: mmol/L
107  (4.6) 104  (3.0)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Saline Group Isolyte Group
Hide Arm/Group Description

0.9% Normal Saline (0.9% Sodium Chloride) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients.

0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte S (B Braun, Irvine CA) injection intravenously as needed. The amount administered (dosage, frequency, and duration) will be left to the clinical judgment of the attending physicians, and will follow usual patterns of use in cardiac surgery patients. Isolyte S is a prepackaged solution containing sodium chloride 0.53%, sodium gluconate 0.5%, sodium acetate trihydrate 0.37%, potassium chloride 0.037%, and magnesium chloride hexahydrate 0.03% w/v.

Isolyte S injection

All-Cause Mortality
Normal Saline Group Isolyte Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Normal Saline Group Isolyte Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Saline Group Isolyte Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Neal Gerstein, MD
Organization: Dept of Anesthesiology, University of New Mexico
Phone: 5052722610
Responsible Party: Neal Gerstein, University of New Mexico
ClinicalTrials.gov Identifier: NCT02668952     History of Changes
Other Study ID Numbers: 15-572
First Submitted: January 20, 2016
First Posted: January 29, 2016
Results First Submitted: February 15, 2018
Results First Posted: March 19, 2018
Last Update Posted: May 14, 2018