Fluid Responsiveness Evaluation in Sepsis-associated Hypotension

NCT02837731 | Completed Results DMC FDA Device

• 1 other identifier: PRO-OOO1
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 12

Brief Summary

This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.

Conditions

Sepsis; Hypotension

Outcome Measures

Primary Outcomes (1)

• Fluid Balance

  Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments.

  72 hours

Secondary Outcomes (6)

• Percentage of Participants Requiring Renal Replacement Therapy

  Day 1 to Day 30

• Percentage of Participants Requiring Ventilator Use

  Day 1 to Day 30

• Length of ICU Stay

  Day 1 to Day 30

• Number of Hours of Ventilator Use

  Day 1 to Day 30

• Number of Hours of Vasopressor Use

  Day 1 to Day 30

Other Outcomes (6)

• Volume of Fluid

  72 hours

• Percentage of Participants With Major Adverse Cardiac Event (MACE)

  Day 1 to Day 30

• Number of Participants Experiencing an Adverse Event (AE) Related to Study Device

  Day 1 to Day 30

Study Arms (2)

Treatment Starling SV monitor

EXPERIMENTAL

A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of \< 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) to guide corresponding treatment.

Device: Treatment Starling SV monitor

Control

NO INTERVENTION

No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.

Interventions

Treatment Starling SV monitor DEVICE

A dynamic assessment of fluid responsiveness will be performed at every clinical decision point for the first 72 hours of study enrollment. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.

Treatment Starling SV monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of sepsis, as exhibited by 2 or more of the following systemic inflammatory response syndrome (SIRS) criteria and a known or presumed infection at time of screening:
• Temperature of \> 38 C or \< 36 C
• Heart rate of \> 90/min
• Respiratory rate of \> 20/min or PaCO2 \< 32 mm Hg (4.3 kPA)
• White blood cell count \> 12000/mm3 or \< 4000/mm3 or \>10% immature bands
• Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid)
• Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within 24 hours of arrival to the hospital
• Anticipated ICU admission
• Able to provide signed informed consent or consent can be obtained from the patient's authorized representative

You may not qualify if:

• Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
• Known aortic insufficiency, or aortic abnormalities
• Hemodynamic instability due to active gastrointestinal hemorrhage
• Patient has received \>3 liters of IV fluid prior to study randomization
• Requires immediate surgery
• Patient transferred to the ICU from another hospital unit
• Do not attempt resuscitation (DNAR or DNR) order
• Advanced directives restricting implementation of the resuscitation protocol
• Contraindication to blood transfusion
• Attending clinician deems aggressive resuscitation unsuitable
• Transferred from another in-hospital setting
• Not able to commence treatment protocol within 1 hour after randomization
• Known intraventricular heart defect, such as ventral septal defect or atrial septal defect
• Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to determine fluid responsiveness
• Seizure in the last 24 hours

Sponsors & Collaborators

• Cheetah Medical Inc.: lead

Study Sites (12)

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

New York Presbyterian Brooklyn Methodist Hospital

New York, New York, 11215, United States

Location

Ohio State University Hospital

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Royal Surrey County Hospital

Guildford, United Kingdom

Location

Related Publications (1)

• Douglas IS, Alapat PM, Corl KA, Exline MC, Forni LG, Holder AL, Kaufman DA, Khan A, Levy MM, Martin GS, Sahatjian JA, Seeley E, Self WH, Weingarten JA, Williams M, Hansell DM. Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial. Chest. 2020 Oct;158(4):1431-1445. doi: 10.1016/j.chest.2020.04.025. Epub 2020 Apr 27.

  PMID: 32353418 DERIVED

MeSH Terms

Conditions

Sepsis; Hypotension

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Baxter Clinical Trials Disclosure Call Center
• Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 20, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 13, 2019
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); US (11)