N/A
N=974
Isotonic Solution Administration Logistical Testing
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02345486 ↗Enrolled (actual)
974
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Proportion of Isotonic Crystalloid Which is 0.9% Saline — 91.2; 21.0 Percentage of fluid that was saline — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0.9% sodium chloride (Other); Physiologically balanced fluid (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Isotonic Crystalloid Which is 0.9% Saline |
91.2; 21.0 | 0.001 sig |
| SECONDARY Proportion of Isotonic Crystalloid Which is Physiologically Balanced |
8.8; 78.8 | — |
| SECONDARY Total Intravenous Input |
2000; 2125 | — |
| SECONDARY Total Isotonic Crystalloid Input |
1424; 1617 | — |
| SECONDARY Total Intravenous Colloid Input |
0; 0 | — |
| SECONDARY Total Intravenous Blood Product Administration |
0; 0 | — |
| SECONDARY Highest Serum Chloride Between Enrollment and Day 30 |
109; 108 | — |
| SECONDARY Highest Serum Sodium Between Enrollment and Day 30 |
141; 141 | — |
| SECONDARY Lowest Bicarbonate Concentration Between Enrollment and Day 30 |
19; 19 | — |
| SECONDARY Number of Patients With MAKE30 |
112; 128 | — |
| SECONDARY In-hospital Mortality |
68; 72 | — |
| SECONDARY New Use of Renal Replacement Therapy |
14; 24 | — |
| SECONDARY Persistent Renal Dysfunction |
59; 76 | — |
| SECONDARY Number of Contraindications |
28; 66 | — |
| SECONDARY Incidence of Hyperchloremia |
171; 171 | — |
| SECONDARY Incidence of Severe Hypochloremia |
34; 32 | — |
| SECONDARY Increase in Serum Creatinine |
0.07; 0.07 | — |
| SECONDARY Incidence of Acute Kidney Injury |
129; 135 | — |
| SECONDARY Intensive Care Unit Free Days to Day 28 |
25.1; 25.2 | — |
| SECONDARY Ventilator-free Days (VFD) to Day 28 |
28.0; 28.0 | — |
| SECONDARY Dialysis-free Survival to Day 28 |
28.0; 28.0 | — |
| SECONDARY Peak Creatinine in the First 30 Days |
1.19; 1.19 | — |
Summary
The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.
Eligibility Criteria
Inclusion Criteria
- Admitted to the adult medical intensive care unit (MICU) at Vanderbilt University Medical Center
Exclusion Criteria
- Age<18 years old
Data sourced from ClinicalTrials.gov (NCT02345486). 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.