Variation in Fluids Administered in Shock (VOLUME)

Observation of Variation in Fluids Administered and Characterization of Vasopressor Requirements in Shock

To conduct a multicenter observational cohort study to determine the variability in fluid resuscitation in shock in a broad range of areas in hospitals and treatment areas.

Study Overview

• Status: Completed
• Conditions: Shock
• Intervention / Treatment: Other: Fluids

• Study Type: Observational
• Enrollment (Actual): 1639

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with shock

Description

Inclusion Criteria:

• Age ≥ 18 years admitted to the participating hospital.
• Patients in the emergency department, intensive care unit, PACU, or any hospital floor. For patients not in the ICU, there must be plans to transfer to an intensive care unit when an ICU bed is available for patient.
• Patients with shock as defined by:
• Need for vasopressor (dopamine, norepinephrine, or epinephrine at any dose) to keep MAP > 65 mmHg Or
• Systolic BP < 90 mmHg

Exclusion Criteria:

• Patients previously enrolled into this study.
• Patients who were in the operating room at time of shock and fluid bolus.
• Patients admitted to an ICU after cardiac surgery Patients with primarily cardiogenic shock as etiology for their shock
• Patients transferred from another hospital or emergency room to the study hospital.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shock	Other: Fluids; Fluids Administered in Shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method used to guide volume resuscitation	Characterize the method used to guide volume resuscitation and vasopressor use in patients with shock	7 days

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 2017-7860

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No