Isotonic Solution Administration Logistical Testing (SALT)

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ClinicalTrials.gov Identifier: NCT02345486

Recruitment Status : Completed

First Posted : January 26, 2015

Last Update Posted : April 20, 2017

Sponsor:

Information provided by (Responsible Party):

Todd Rice, Vanderbilt University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Kidney Injury	Other: 0.9% sodium chloride Other: Physiologically balanced fluid	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	974 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial
Study Start Date :	February 2015
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sodium chloride Normosol R Plasmalyte A PlasmaLyte Plasmalyte 148

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Other: 0.9% sodium chloride
Active Comparator: 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.	Other: Physiologically balanced fluid Other Name: Lactated ringers or Plasmalyte-A

Outcome Measures

Primary Outcome Measures :

Proportion of isotonic crystalloid which is 0.9% saline [ Time Frame: 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.

Secondary Outcome Measures :

Proportion of isotonic crystalloid which is physiologically balanced [ Time Frame: 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 [ Time Frame: 30 days ]
Total volume of intravenous fluid administration during admission to the intensive care unit, censored at 30 days
Total Isotonic Crystalloid Input [ Time Frame: 30 days ]
Total volume of intravenous isotonic crystalloid administration during admission to the intensive care unit, censored at 30 days
Total Intravenous Colloid Input [ Time Frame: 30 days ]
Total volume of intravenous colloid administration (excluding blood products) during admission to the intensive care unit, censored at 30 days
Total Intravenous Blood Product Administration [ Time Frame: 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
Time-weighted mean chloride [ Time Frame: 30 days ]
Time-weighted mean serum chloride concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Time-weighted mean sodium [ Time Frame: 30 days ]
Time-weighted mean serum sodium concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Time-weighted mean bicarbonate [ Time Frame: 30 days ]
Time-weighted mean serum bicarbonate concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
MAKE30 Incidence [ Time Frame: 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)
In-hospital mortality [ Time Frame: 30 days ]
Death prior to the earlier of hospital discharge or day 30
New use of renal replacement therapy [ Time Frame: 30 days ]
Receipt of new renal replacement therapy after the first study day, censored at 30 days
Persistent renal dysfunction [ Time Frame: 30 days ]
Persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)
Number of contraindications [ Time Frame: 30 days ]
Number of contraindications to assigned study fluid identified by providers, censored at 30 days
Incidence of severe hyperchloremia [ Time Frame: 30 days ]
Incidence of severe hyperchloremia defined as a serum chloride greater than or equal to 114 mmol/L
Incidence of severe hypochloremia [ Time Frame: 30 days ]
Incidence of severe hypochloremia defined as a serum chloride less than 90mmol/L
Increase in serum creatinine [ Time Frame: 30 days ]
Increase in serum creatinine during hospitalization, censored at 30 days
Incidence of acute kidney injury [ Time Frame: 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
Intensive care unit free days to day 28 [ Time Frame: 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 to day 28 [ Time Frame: 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.
Dialysis-free survival to day 28 [ Time Frame: 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.
Peak creatinine in the first 28 days [ Time Frame: 28 days ]
Highest creatinine value in the first 28 days

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age<18 years old

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345486

Locations

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37209

Sponsors and Collaborators

Vanderbilt University

Investigators

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Principal Investigator:	Todd W Rice, M.D., M.Sc.	Vanderbilt University Medical Center

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Todd Rice, Assistant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT02345486 History of Changes
Other Study ID Numbers:	141349
First Posted:	January 26, 2015 Key Record Dates
Last Update Posted:	April 20, 2017
Last Verified:	April 2017

Keywords provided by Todd Rice, Vanderbilt University:


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

Additional relevant MeSH terms:

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Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases	Plasma-lyte 148 Ophthalmic Solutions Pharmaceutical Solutions

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