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Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit (SMART-MED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Todd Rice, Vanderbilt University Medical Center
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT02444988
First received: May 11, 2015
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).

Condition Intervention Phase
Critical Illness
Acute Kidney Injury
Other: 0.9% Saline
Other: Physiologically-balanced isotonic crystalloid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Todd Rice, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Major Adverse Kidney Events by hospital discharge or day 30 [ Time Frame: 30 days after enrollment censored at hospital discharge ]
    The primary endpoint will be considered present if at least one of the following occur: (1) A patient dies prior to the earlier of hospital discharge or day 30; (2) A patient receives new renal replacement therapy between enrollment and day 30, or (3) A patient has persistent renal dysfunction at the earlier of hospital discharge or day 30 (persistent renal dysfunction is defined as ≥ 200% of creatinine from baseline)


Secondary Outcome Measures:
  • 30-day In-hospital mortality [ Time Frame: 30 days after enrollment censored at hospital discharge ]
    Death before hospital discharge, censored at 30 days after enrollment

  • New Renal Replacement Therapy by day 30 [ Time Frame: 30 days after enrollment censored at hospital discharge ]
    The initiation of any renal replacement therapy between enrollment and 30 days censored at hospital discharge in a patient not known to have previously received renal replacement therapy.

  • Persistent renal dysfunction [ Time Frame: At the first of 30 days after enrollment or hospital discharge ]
    Final creatinine value before discharge or 30 days after enrollment ≥ 200% of baseline creatinine.

  • Intensive care unit (ICU) mortality [ Time Frame: 30 days after enrollment censored at ICU discharge ]
  • Hospital mortality [ Time Frame: 30 days after enrollment censored at hospital discharge ]
  • 60-day mortality [ Time Frame: 60 days after enrollment ]
  • Intensive care unit free days to day 28 [ Time Frame: 28 days after enrollment ]
    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 after the patient's final discharge from the intensive care unit before 28 days. If the patient is admitted to an intensive care unit 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 after enrollment ]
    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, ventilator-free days 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, ventilator-free days will be 0.

  • Vasopressor-free days to day 28 [ Time Frame: 28 days after enrollment ]
    Vasopressor-free days to 28 days after enrollment will be defined as the number of days alive and not on vasopressors before 28 days. If the patient is on vasopressors at day 28 or dies prior to day 28, vasopressor-free days will be 0.

  • Renal replacement therapy-free survival to day 28 [ Time Frame: 28 days after enrollment ]
    Renal replacement therapy-free days to 28 days after enrollment will be defined as the number of days alive and not receiving renal replacement therapy after the final episode of renal replacement therapy during the hospitalization. If the patient dies or continues to receive renal replacement therapy at the time of discharge, the value will be 0.

  • Highest creatinine in the first 28 days [ Time Frame: 28 days after enrollment ]
  • Change from baseline creatinine to highest creatinine in the first 28 days [ Time Frame: 28 days after enrollment ]
  • Highest serum chloride in the 28 days after enrollment [ Time Frame: 28 days after enrollment ]
  • Lowest serum bicarbonate in the 28 days after enrollment [ Time Frame: 28 days after enrollment ]
  • Highest serum potassium in the 28 days after enrollment [ Time Frame: 28 days after enrollment ]
  • Lowest serum potassium in the 28 days after enrollment [ Time Frame: 28 days after enrollment ]
  • Change in serum chloride over the 28 days after enrollment [ Time Frame: 28 days after enrollment ]
  • Change in serum bicarbonate over the 28 days after enrollment [ Time Frame: 28 days after enrollment ]

Estimated Enrollment: 5300
Study Start Date: June 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.9% Saline
Patients in an ICU block randomized to physiologically-balanced isotonic fluid will receive 0.9% Saline whenever isotonic intravenous fluid administration is ordered by the treating provider.
Other: 0.9% Saline
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Other Names:
  • Normal Saline
  • 0.9% sodium chloride
Active Comparator: Physiologically-balanced
Patients in an ICU block randomized to physiologically-balanced isotonic fluid will receive Plasma-Lyte© A or Lactated Ringer's whenever isotonic intravenous fluid administration is ordered by the treating provider.
Other: Physiologically-balanced isotonic crystalloid
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
Other Names:
  • Lactated Ringers
  • Ringer's Lactate
  • Plasma-Lyte© A

Detailed Description:
SMART-MED is a large, cluster-randomized, multiple-crossover trial of 0.9% saline versus physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasma-Lyte© A) with regard to the incidence of major adverse kidney events by 30 days in patients admitted to the medical intensive care unit. Between June 2015 and April 2017, all patients admitted to the medical intensive care unit at Vanderbilt University medical center who are 18 years or older will be enrolled. The study will occur in one-month blocks. The ICU will be randomized to an initial fluid group (0.9% saline or physiologically balanced crystalloids). The assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). The assigned study fluid will switch at the end of each month-long block such that half of the months are assigned to 0.9% saline and half of the months are assigned to physiologically balance fluid. It is anticipated that around 5,300 patients will be enrolled from the medical ICU during the study period. All aspects of study design, intervention, and data collection will be harmonized with an independent study addressing the same question in the non-medical intensive care units at Vanderbilt University during a similar study period (SMART-SURG). A pre-specified data analysis plan will dictate the harmonized analysis of SMART-MED and SMART-SURG.
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Age<18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02444988

Contacts
Contact: Matthew W Semler, M.D. (615) 322-3412 matthew.w.semler@vanderbilt.edu
Contact: Todd W Rice, M.D. (615) 322-3412 todd.rice@Vanderbilt.Edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37209
Contact: Matthew W Semler, M.D.    615-802-8428    matthew.semler@gmail.com   
Contact: Todd W Rice, M.D., M.Sc.    (615) 322-3412    todd.rice@vanderbilt.edu   
Principal Investigator: Todd W Rice, M.D., M.Sc.         
Sub-Investigator: Matthew W Semler, M.D.         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Todd W Rice, M.D. Vanderbilt University
  More Information

Publications:
Responsible Party: Todd Rice, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02444988     History of Changes
Other Study ID Numbers: IRB#141349
Study First Received: May 11, 2015
Last Updated: December 12, 2016

Keywords provided by Todd Rice, Vanderbilt University Medical Center:
crystalloid
acute kidney injury

Additional relevant MeSH terms:
Acute Kidney Injury
Critical Illness
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on May 25, 2017