Mode
Text Size
Log in / Sign up
N/A N=974 Randomized Treatment

Isotonic Solution Administration Logistical Testing

Acute Kidney Injury

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search