NCT03190408

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,639

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

June 14, 2017

Last Update Submit

July 21, 2020

Conditions

Shock

Outcome Measures

Primary Outcomes (1)

  • Method used to guide volume resuscitation

    Characterize the method used to guide volume resuscitation and vasopressor use in patients with shock

    7 days

Study Arms (1)

Shock

Other: Fluids

Interventions

FluidsOTHER

Fluids Administered in Shock

Shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with shock

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Shock

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

September 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

US(1)