Variation in Fluids Administered in Shock | NCT03190408

Studies
Variation in Fluids Administered in Shock

NCT03190408

Sponsor

Montefiore Medical Center

Status

Completed

Last Update Posted

Jul 23, 2020Actual

Enrollment

1,639Actual

Phase

Not provided

Conditions

Shock

Interventions

Fluids

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Feb 1, 2018Actual

Completion Date

Feb 1, 2018Actual

First Submitted Date

Jun 14, 2017

First Submission Date that Met QC Criteria

Jun 14, 2017

First Posted Date

Jun 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2020

Last Update Posted Date

Jul 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,639Actual

Label	Type	Description	Intervention Names
Shock			Other: Fluids

Name	Type	Description	Arm Group Labels	Other Names
Fluids	Other	Fluids Administered in Shock	Shock

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with shock

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montefiore Medical Center		The Bronx	New York	10461	United States

Condition Browse Module

MeSH Terms

ID	Term
D012769	Shock

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005440	Fluid Therapy

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided