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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02473718
Recruitment Status : Completed
First Posted : June 16, 2015
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Septic Shock Fluid Therapy Hypotension Other: Fluid minimization protocol Device: Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Fluid minimization group
Patients in the fluid minimization arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ. A fluid challenge in the form of a leg raise or infusion of 250 mL of crystalloid over 5 minutes will then be performed and the parameters repeated. The patient will be judged to be fluid responsive or nonresponsive based on the changes in the parameters. Fluid nonresponsive patients will receive the intervention of the fluid minimization protocol by concentrating continuous infusions, discontinuing maintenance fluids, and minimizing carrier fluids. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance.
Other: Fluid minimization protocol
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.

Device: Ultrasound
No Intervention: Usual care group
Patients in the usual care arm will have daily fluid intake and output, baseline central venous pressure, mean arterial pressure, central venous oxygen saturation, pulse pressure variation, and inferior vena cava diameters during inspiration and expiration recorded by a dedicated research fellow. Patients who are intubated will also have corrected flow time, stroke volume, cardiac output, and cardiac index recorded via CardioQ.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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:

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

Exclusion Criteria:

  1. Patients with a history of end-stage renal disease requiring outpatient dialysis
  2. Patients whose goals of care are consistent with comfort measures only
  3. Pregnant patients
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02473718    
Other Study ID Numbers: 201310111
First Posted: June 16, 2015    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Shock, Septic
Hypotension
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vascular Diseases
Cardiovascular Diseases