Clinical trial NCT02345486: Isotonic Solution Administration Logistical Testing
Official title: Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Pilot Projects
Plasmalyte A
Ringer's lactate
Sodium Chloride
Critical Care
Resuscitation"
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Proportion of Isotonic Crystalloid Which is 0.9% Saline
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of Isotonic Crystalloid Which is Physiologically Balanced
timeFrame: 30 days
measure: Total Intravenous Input
timeFrame: 30 days
measure: Total Isotonic Crystalloid Input
timeFrame: 30 days
measure: Total Intravenous Colloid Input
timeFrame: 30 days
measure: Total Intravenous Blood Product Administration
timeFrame: 30 days
measure: Highest Serum Chloride Between Enrollment and Day 30
timeFrame: 30 days
measure: Highest Serum Sodium Between Enrollment and Day 30
timeFrame: 30 days
measure: Lowest Bicarbonate Concentration Between Enrollment and Day 30
timeFrame: 30 days
measure: Number of Patients With MAKE30
timeFrame: 30 days
measure: In-hospital Mortality
timeFrame: 30 days
measure: New Use of Renal Replacement Therapy
timeFrame: 30 days
measure: Persistent Renal Dysfunction
timeFrame: 30 days
measure: Number of Contraindications
timeFrame: 30 days
measure: Incidence of Hyperchloremia
timeFrame: 30 days
measure: Incidence of Severe Hypochloremia
timeFrame: 30 days
measure: Increase in Serum Creatinine
timeFrame: 30 days
measure: Incidence of Acute Kidney Injury
timeFrame: 30 days
measure: Intensive Care Unit Free Days to Day 28
timeFrame: 28 days
measure: Ventilator-free Days (VFD) to Day 28
timeFrame: 28 days
measure: Dialysis-free Survival to Day 28
timeFrame: 28 days
measure: Peak Creatinine in the First 30 Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Todd W Rice, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.
citation: Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
citation: Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
citation: Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, Wang L, Byrne DW, Shaw AD, Bernard GR, Rice TW; SALT Investigators * and the Pragmatic Critical Care Research Group; SALT Investigators. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1362-1372. doi: 10.1164/rccm.201607-1345OC.