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

Primary Purpose

Septic Shock, Fluid Therapy, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid minimization protocol
Ultrasound
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Fluid minimization group

    Usual care group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Cumulative Fluid Administered
    Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3
    Cumulative Fluid Administered
    Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5
    Net Fluid Balance
    Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3
    Net Fluid Balance
    Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5

    Secondary Outcome Measures

    Ventilator Days
    Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation
    Rate of Renal Replacement Therapy
    Percentage of patients requiring renal replacement therapy
    Mortality
    Percentage of patients who died during their hospitalization
    Mortality
    Percentage of patients who died during their ICU stay

    Full Information

    First Posted
    June 10, 2015
    Last Updated
    February 27, 2018
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02473718
    Brief Title
    Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock
    Official Title
    Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock, Fluid Therapy, Hypotension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluid minimization group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual care group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Fluid minimization protocol
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Primary Outcome Measure Information:
    Title
    Cumulative Fluid Administered
    Description
    Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3
    Time Frame
    Day 3
    Title
    Cumulative Fluid Administered
    Description
    Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5
    Time Frame
    Day 5
    Title
    Net Fluid Balance
    Description
    Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3
    Time Frame
    Day 3
    Title
    Net Fluid Balance
    Description
    Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5
    Time Frame
    Day 5
    Secondary Outcome Measure Information:
    Title
    Ventilator Days
    Description
    Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation
    Time Frame
    Hospital stay, median of 16 days
    Title
    Rate of Renal Replacement Therapy
    Description
    Percentage of patients requiring renal replacement therapy
    Time Frame
    ICU stay, median of 10 days
    Title
    Mortality
    Description
    Percentage of patients who died during their hospitalization
    Time Frame
    Hospital stay, median of 16 days
    Title
    Mortality
    Description
    Percentage of patients who died during their ICU stay
    Time Frame
    ICU stay, median of 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10858412
    Citation
    Alsous F, Khamiees M, DeGirolamo A, Amoateng-Adjepong Y, Manthous CA. Negative fluid balance predicts survival in patients with septic shock: a retrospective pilot study. Chest. 2000 Jun;117(6):1749-54. doi: 10.1378/chest.117.6.1749.
    Results Reference
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    PubMed Identifier
    11445675
    Citation
    Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
    Results Reference
    background
    PubMed Identifier
    23353941
    Citation
    Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
    Results Reference
    background
    PubMed Identifier
    10903232
    Citation
    Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8. doi: 10.1164/ajrccm.162.1.9903035.
    Results Reference
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    PubMed Identifier
    12065368
    Citation
    Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
    Results Reference
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    PubMed Identifier
    18628220
    Citation
    Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331.
    Results Reference
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    PubMed Identifier
    17900477
    Citation
    Marik PE, Baram M. Noninvasive hemodynamic monitoring in the intensive care unit. Crit Care Clin. 2007 Jul;23(3):383-400. doi: 10.1016/j.ccc.2007.05.002.
    Results Reference
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    PubMed Identifier
    11794169
    Citation
    Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
    Results Reference
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    PubMed Identifier
    16424713
    Citation
    Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.
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    PubMed Identifier
    16714767
    Citation
    National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
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    Citation
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    Results Reference
    derived

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