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OpenTrials
Completed

NCT Number: NCT02473718

Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock

The purpose of the study is to determine if a protocol that assesses patients' daily fluid intake and output can decrease the overall amount of fluid patients receive during the first five days in the ICU. The study will also determine if decreasing overall fluids can decrease adverse events associated with mechanical ventilation, such as ventilator-associated pneumonias.

The protocol will include daily ultrasounds and blood draws to evaluate fluid balance. Ultrasound will be used to measure changes in the diameter of the inferior vena cava with respiration.

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Key information

Conditions

Septic Shock Cardiovascular Diseases Fluid Therapy Hypotension Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient with septic shock as the primary cause of hypotension
  • Requiring vasopressors for 12 hours after adequate fluid resuscitation and at the time of enrollment

Exclusion criteria

  • Patients with a history of end-stage renal disease requiring outpatient dialysis
  • Patients whose goals of care are consistent with comfort measures only
  • Pregnant patients

Treatment and study plan

Fluid minimization protocol

Other

Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance in patients demonstrating fluid non-responsiveness.

Ultrasound

Device

Primary outcomes

  1. Cumulative Fluid Administered

    Time frame: Day 3

    Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3

  2. Cumulative Fluid Administered

    Time frame: Day 5

    Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5

  3. Net Fluid Balance

    Time frame: Day 3

    Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3

  4. Net Fluid Balance

    Time frame: Day 5

    Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5

Secondary outcomes

  1. Ventilator Days

    Time frame: Hospital stay, median of 16 days

    Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation

  2. Rate of Renal Replacement Therapy

    Time frame: ICU stay, median of 10 days

    Percentage of patients requiring renal replacement therapy

  3. Mortality

    Time frame: Hospital stay, median of 16 days

    Percentage of patients who died during their hospitalization

  4. Mortality

    Time frame: ICU stay, median of 10 days

    Percentage of patients who died during their ICU stay

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 16, 2015
Registry last updated
Jul 24, 2024

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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