Isotonic Solution Administration Logistical Testing (SALT)

Vanderbilt University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Other: Physiologically balanced fluid; Other: 0.9% sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02345486

141349

Details and patient eligibility

About

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.

Enrollment: 974 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Age<18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

974 participants in 2 patient groups

0.9% sodium chloride

Active Comparator group

Description:

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.

Treatment:

Other: 0.9% sodium chloride

Physiologically balanced fluid

Active Comparator group

Description:

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.

Treatment:

Other: Physiologically balanced fluid