Trial Outcomes & Findings for Fluid Chloride and AKI in Cardiopulmonary Bypass (NCT NCT02668952)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Baseline and postoperatively at 24 hours

Results posted on

2018-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Normal Saline Group 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 Group 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 Study STARTED	16	14
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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 n=30 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 11.0 • n=16 Participants	62.8 years STANDARD_DEVIATION 9.4 • n=14 Participants	64.1 years STANDARD_DEVIATION 10.2 • n=30 Participants
Sex: Female, Male Female	6 Participants n=16 Participants	8 Participants n=14 Participants	14 Participants n=30 Participants
Sex: Female, Male Male	10 Participants n=16 Participants	6 Participants n=14 Participants	16 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	16 Participants n=16 Participants	14 Participants n=14 Participants	30 Participants n=30 Participants
[TIMP2] x [IGFBP7]	0.101 (ng/mL)^2/1000 STANDARD_DEVIATION 0.096 • n=16 Participants	0.116 (ng/mL)^2/1000 STANDARD_DEVIATION 0.138 • n=14 Participants	0.108 (ng/mL)^2/1000 STANDARD_DEVIATION 0.115 • n=30 Participants
Serum creatinine	0.93 mg/dL STANDARD_DEVIATION 0.18 • n=16 Participants	0.88 mg/dL STANDARD_DEVIATION 0.14 • n=14 Participants	0.91 mg/dL STANDARD_DEVIATION 0.16 • n=30 Participants
Serum chloride	108 mmol/L STANDARD_DEVIATION 3.1 • n=16 Participants	106 mmol/L STANDARD_DEVIATION 3.4 • n=14 Participants	107 mmol/L STANDARD_DEVIATION 3.2 • n=30 Participants

PRIMARY outcome

Timeframe: Baseline and postoperatively at 24 hours

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

Outcome measures

Outcome measures
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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
Change in [TIMP2]*[IGFBP7] Biomarker	0.015 (ng/mL)^2/1000 Standard Deviation 0.125	0.009 (ng/mL)^2/1000 Standard Deviation 0.148

SECONDARY outcome

Timeframe: 1 day

Serum creatinine measurement at 24 hours

Outcome measures

Outcome measures
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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
Serum Creatinine Level at 24 Hours	0.85 mg/dL Standard Deviation 0.24	0.80 mg/dL Standard Deviation 0.16

SECONDARY outcome

Timeframe: 1 day

Serum chloride ion measurement at 24 hours postoperatively

Outcome measures

Outcome measures
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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
Serum Chloride Level at 24 Hours	110 mmol/L Standard Deviation 3.0	106 mmol/L Standard Deviation 3.1

SECONDARY outcome

Timeframe: One week

Clinically-determined need for dialysis prior to discharge from hospital

Outcome measures

Outcome measures
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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
Proportion of Patients With Need for Dialysis	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: One day

Arterial pH, measured 24 hours after surgery

Outcome measures

Outcome measures
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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
Postoperative Arterial pH	7.38 pH Standard Deviation 0.03	7.41 pH Standard Deviation 0.05

SECONDARY outcome

Timeframe: 2 days

Serum creatinine level 48 hours postoperatively

Outcome measures

Outcome measures
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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
Serum Creatinine Level at 48 Hours	0.91 mg/dL Standard Deviation 0.31	0.74 mg/dL Standard Deviation 0.14

SECONDARY outcome

Timeframe: 2 days

Serum chloride measurement at 48 hours postoperatively

Outcome measures

Outcome measures
Measure	Normal Saline Group n=16 Participants 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 Group n=14 Participants 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
Serum Chloride at 48 Hours	107 mmol/L Standard Deviation 4.6	104 mmol/L Standard Deviation 3.0

Adverse Events

Normal Saline Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Isolyte Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Neal Gerstein, MD

Dept of Anesthesiology, University of New Mexico

Phone: 5052722610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place