Isotonic Solution Administration Logistical Testing

NCT02345486 | Completed Results

• 1 other identifier: 141349
• Study Type: interventional
• Target: 974
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Pilot Projects; Plasmalyte A; Ringer's lactate; Sodium Chloride; Critical Care; Resuscitation"

Outcome Measures

Primary Outcomes (1)

• Proportion of Isotonic Crystalloid Which is 0.9% Saline

  Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is 0.9% sodium chloride, censored at 30 days. The primary outcome was the proportion of intravenous isotonic crystalloid administered in the ICU that was saline. This was a continuous variable calculated for each patient as the volume of saline received divided by volume of saline received plus volume of balanced crystalloids received with a range from 0.0 (no saline received) to 1.0 (only saline received).

  30 days

Secondary Outcomes (21)

• Proportion of Isotonic Crystalloid Which is Physiologically Balanced

  30 days

• Total Intravenous Input

  30 days

• Total Isotonic Crystalloid Input

  30 days

• Total Intravenous Colloid Input

  30 days

• Total Intravenous Blood Product Administration

  30 days

Study Arms (2)

0.9% sodium chloride

ACTIVE COMPARATOR

Participants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.

Other: 0.9% sodium chloride

Physiologically balanced fluid

ACTIVE COMPARATOR

Participants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission.

Other: Physiologically balanced fluid

Interventions

0.9% sodium chloride OTHER

0.9% sodium chloride

Physiologically balanced fluid OTHER

Also known as: Lactated ringers or Plasmalyte-A

Physiologically balanced fluid

Eligibility Criteria

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

You may qualify if:

• Admitted to the adult medical intensive care unit (MICU) at Vanderbilt University Medical Center

You may not qualify if:

• Age\<18 years old

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37209, United States

Location

Related Publications (4)

• 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.

  PMID: 21705897 BACKGROUND

• 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.

  PMID: 23073953 BACKGROUND

• 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.

  PMID: 24674927 BACKGROUND

• 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.

  PMID: 27749094 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Chloride; Ringer's Lactate; Plasmalyte A

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)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Matthew Semler
• Organization: Vanderbilt University Medical Center

matthew.w.semler@vumc.org

615-322-3412

Study Officials

• Todd W Rice, M.D., M.Sc.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 13, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Locations

US (1)