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Completed

NCT Number: NCT02345486

Isotonic Solution Administration Logistical Testing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age<18 years old

Treatment and study plan

0.9% Sodium Chloride

Other

Physiologically balanced fluid

Other

Other names: Lactated ringers or Plasmalyte-A

Primary outcomes

  1. 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. 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 outcomes

  1. 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.

  2. Total Intravenous Input

    Time frame: 30 days

    Total volume of intravenous fluid administration during admission to the intensive care unit, censored at 30 days

  3. 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

  4. 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

  5. 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

  6. Highest Serum Chloride Between Enrollment and Day 30

    Time frame: 30 days

    highest serum chloride (mmol/L) during admission to the intensive care unit, censored at 30 days

  7. Highest Serum Sodium Between Enrollment and Day 30

    Time frame: 30 days

    Highest serum sodium concentration (mmol/L) during admission to the intensive care unit, censored at 30 days

  8. Lowest Bicarbonate Concentration Between Enrollment and Day 30

    Time frame: 30 days

    Lowest serum bicarbonate concentration (mmol/L) during admission to the intensive care unit, censored at 30 days

  9. Number of Patients With MAKE30

    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)

  10. In-hospital Mortality

    Time frame: 30 days

    Death prior to the earlier of hospital discharge or day 30

  11. 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

  12. 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)

  13. Number of Contraindications

    Time frame: 30 days

    Number of contraindications to assigned study fluid identified by providers, censored at 30 days

  14. Incidence of Hyperchloremia

    Time frame: 30 days

    Incidence of hyperchloremia defined as a serum chloride greater than or equal to 110 mmol/L

  15. Incidence of Severe Hypochloremia

    Time frame: 30 days

    Incidence of severe hypochloremia defined as a serum chloride less than 90mmol/L

  16. Increase in Serum Creatinine

    Time frame: 30 days

    Increase in serum creatinine during hospitalization, censored at 30 days Change from baseline to highest value, median (IQR), mg/dl

  17. 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

  18. 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.

  19. Ventilator-free Days (VFD) 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.

  20. 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.

  21. Peak Creatinine in the First 30 Days

    Time frame: 30 days

    Highest creatinine value in the first 30 days

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Acronym: SALT

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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