Fluid Chloride and AKI in Cardiopulmonary Bypass

NCT02668952 | Completed Phase 2 Results

• 1 other identifier: 15-572
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models, excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients (up to 40 enrolled) into 2 study arms and compare renal outcomes.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Change in [TIMP2]*[IGFBP7] Biomarker

  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

  Baseline and postoperatively at 24 hours

Secondary Outcomes (6)

• Serum Creatinine Level at 24 Hours

  1 day

• Serum Chloride Level at 24 Hours

  1 day

• Proportion of Patients With Need for Dialysis

  One week

• Postoperative Arterial pH

  One day

• Serum Creatinine Level at 48 Hours

  2 days

Study Arms (2)

Normal Saline group

ACTIVE COMPARATOR

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.

Drug: 0.9% Normal Saline (0.9% Sodium Chloride) injection

Isolyte group

EXPERIMENTAL

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.

Drug: Isolyte S injection

Interventions

0.9% Normal Saline (0.9% Sodium Chloride) injection DRUG

Normal Saline group

Isolyte S injection DRUG

Isolyte group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned on- or off-pump cardiac surgery including: bypass grafting, valvular procedures, congenital defect correction, and thoracic aortic procedures or a combination of these procedures

You may not qualify if:

• Emergency surgery
• Pregnancy
• Previous renal transplantation
• Documented moderate to severe acute kidney injury prior to enrollment (e.g. RIFLE-I or RIFLE-F/KDIGO stage 2 or 3)
• Patients already receiving dialysis (acute or chronic) or in imminent need of dialysis at time of enrollment
• Chronic kidney disease without baseline serum creatinine value obtained within 6 months of enrollment

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Saline Solution; Sodium Chloride; Injections

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Neal Gerstein, MD
• Organization: Dept of Anesthesiology, University of New Mexico

ngerstein@salud.unm.edu

5052722610

Study Officials

• Neal S Gerstein, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2016
• Primary Completion: February 4, 2017
• Study Completion: February 1, 2018
• Last Updated: May 14, 2018
• Results First Posted: March 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)