Isotonic Solution Administration Logistical Testing

Acute Kidney Injury Clinical Trial

— SALT  

Official title:

Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345486
• Other study ID #: 141349
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 974
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age<18 years old

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• 0.9% sodium chloride

• Physiologically balanced fluid

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Raghunathan K, Shaw A, Nathanson B, Stürmer 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Isotonic Crystalloid Which is Physiologically Balanced	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.	30 days
Secondary	Total Intravenous Input	Total volume of intravenous fluid administration during admission to the intensive care unit, censored at 30 days	30 days
Secondary	Total Isotonic Crystalloid Input	Total volume of intravenous isotonic crystalloid administration during admission to the intensive care unit, censored at 30 days	30 days
Secondary	Total Intravenous Colloid Input	Total volume of intravenous colloid administration (excluding blood products) during admission to the intensive care unit, censored at 30 days	30 days
Secondary	Total Intravenous Blood Product Administration	Total volume of packed red blood cells, platelets, and fresh frozen plasma administered during admission to the intensive care unit, censored at 30 days	30 days
Secondary	Highest Serum Chloride Between Enrollment and Day 30	highest serum chloride (mmol/L) during admission to the intensive care unit, censored at 30 days	30 days
Secondary	Highest Serum Sodium Between Enrollment and Day 30	Highest serum sodium concentration (mmol/L) during admission to the intensive care unit, censored at 30 days	30 days
Secondary	Lowest Bicarbonate Concentration Between Enrollment and Day 30	Lowest serum bicarbonate concentration (mmol/L) during admission to the intensive care unit, censored at 30 days	30 days
Secondary	Number of Patients With MAKE30	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)	30 days
Secondary	In-hospital Mortality	Death prior to the earlier of hospital discharge or day 30	30 days
Secondary	New Use of Renal Replacement Therapy	Receipt of new renal replacement therapy after the first study day, censored at 30 days	30 days
Secondary	Persistent Renal Dysfunction	Persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine = 200% from baseline)	30 days
Secondary	Number of Contraindications	Number of contraindications to assigned study fluid identified by providers, censored at 30 days	30 days
Secondary	Incidence of Hyperchloremia	Incidence of hyperchloremia defined as a serum chloride greater than or equal to 110 mmol/L	30 days
Secondary	Incidence of Severe Hypochloremia	Incidence of severe hypochloremia defined as a serum chloride less than 90mmol/L	30 days
Secondary	Increase in Serum Creatinine	Increase in serum creatinine during hospitalization, censored at 30 days Change from baseline to highest value, median (IQR), mg/dl	30 days
Secondary	Incidence of Acute Kidney Injury	Incidence of stage II or III acute kidney injury by Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury criteria, censored at 30 days	30 days
Secondary	Intensive Care Unit Free Days to Day 28	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.	28 days
Secondary	Ventilator-free Days (VFD) to Day 28	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.	28 days
Secondary	Dialysis-free Survival to Day 28	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.	28 days
Secondary	Peak Creatinine in the First 30 Days	Highest creatinine value in the first 30 days	30 days