Phase 2
N=30
Fluid Chloride and AKI in Cardiopulmonary Bypass
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02668952 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Change in [TIMP2]*[IGFBP7] Biomarker — 0.015; 0.009 (ng/mL)^2/1000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.9% Normal Saline (0.9% Sodium Chloride) injection (Drug); Isolyte S injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in [TIMP2]*[IGFBP7] Biomarker |
0.015; 0.009 | — |
| SECONDARY Serum Creatinine Level at 24 Hours |
0.85; 0.80 | — |
| SECONDARY Serum Chloride Level at 24 Hours |
110; 106 | — |
| SECONDARY Proportion of Patients With Need for Dialysis |
0; 0 | — |
| SECONDARY Postoperative Arterial pH |
7.38; 7.41 | — |
| SECONDARY Serum Creatinine Level at 48 Hours |
0.91; 0.74 | — |
| SECONDARY Serum Chloride at 48 Hours |
107; 104 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02668952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.