Isotonic Solution Administration Logistical Testing

Not Applicable

Completed

Conditions: Acute Kidney Injury

Interventions: Other: 0.9% sodium chloride
Other: Physiologically balanced fluid

Registration Number: NCT02345486

Lead Sponsor: Vanderbilt University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 974

Inclusion Criteria

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

Exclusion Criteria

Age<18 years old

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% sodium chloride	0.9% sodium chloride	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.
Physiologically balanced fluid	Physiologically balanced fluid	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Isotonic Crystalloid Which is 0.9% Saline	30 days	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of Isotonic Crystalloid Which is Physiologically Balanced	30 days	Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is either Lactated ringers or Plasmalyte-A, censored at 30 days.
Total Intravenous Input	30 days	Total volume of intravenous fluid administration during admission to the intensive care unit, censored at 30 days
Total Isotonic Crystalloid Input	30 days	Total volume of intravenous isotonic crystalloid administration during admission to the intensive care unit, censored at 30 days
Total Intravenous Colloid Input	30 days	Total volume of intravenous colloid administration (excluding blood products) during admission to the intensive care unit, censored at 30 days
Persistent Renal Dysfunction	30 days	Persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)
Incidence of Severe Hypochloremia	30 days	Incidence of severe hypochloremia defined as a serum chloride less than 90mmol/L
Total Intravenous Blood Product Administration	30 days	Total volume of packed red blood cells, platelets, and fresh frozen plasma administered during admission to the intensive care unit, censored at 30 days
Lowest Bicarbonate Concentration Between Enrollment and Day 30	30 days	Lowest serum bicarbonate concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Intensive Care Unit Free Days to Day 28	28 days	ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit before 28 days. If the patient is admitted to an intensive care unit service at day 28 or dies prior to day 28, ICU-free days will be 0.
Ventilator-free Days (VFD) to Day 28	28 days	Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing. If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28. If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0.
Highest Serum Sodium Between Enrollment and Day 30	30 days	Highest serum sodium concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Number of Patients With MAKE30	30 days	Incidence of Major Adverse Kidney Events by 30 days -- a composite outcome defined as one or more of the following: death, new use of renal replacement therapy, or persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)
Peak Creatinine in the First 30 Days	30 days	Highest creatinine value in the first 30 days
Incidence of Acute Kidney Injury	30 days	Incidence of stage II or III acute kidney injury by Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury criteria, censored at 30 days
Highest Serum Chloride Between Enrollment and Day 30	30 days	highest serum chloride (mmol/L) during admission to the intensive care unit, censored at 30 days
In-hospital Mortality	30 days	Death prior to the earlier of hospital discharge or day 30
New Use of Renal Replacement Therapy	30 days	Receipt of new renal replacement therapy after the first study day, censored at 30 days
Number of Contraindications	30 days	Number of contraindications to assigned study fluid identified by providers, censored at 30 days
Increase in Serum Creatinine	30 days	Increase in serum creatinine during hospitalization, censored at 30 days Change from baseline to highest value, median (IQR), mg/dl
Incidence of Hyperchloremia	30 days	Incidence of hyperchloremia defined as a serum chloride greater than or equal to 110 mmol/L
Dialysis-free Survival to Day 28	28 days	Dialysis free survival to day 28 will be defined as the number of days alive and without dialysis receipt to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after last receipt of dialysis and remains free of dialysis. If the patient is receiving dialysis at day 28 or dies prior to day 28, VFD will be 0.