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Restrictive Intravenous Fluids Trial in Sepsis

NCT03137446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2018-08-31

No results posted yet for this study

Summary

IV fluid resuscitation has long been recognized to be an important treatment for patients with severe sepsis and septic shock. While under-resuscitation is known to increase morbidity and mortality, contemporary data suggests that overly aggressive fluid resuscitation may also be harmful. Currently, following an initial IVF resuscitation of 30 ml/kg, there is no standard of care and a lack of evidence to support a fluid restrictive or more liberal strategy. The investigators seek to determine if a fluid restrictive strategy reduces morbidity and mortality among patients with severe sepsis and septic shock.

Conditions

  • Septic Shock
  • Severe Sepsis

Interventions

OTHER

Intravenous Fluid Cap

Normal Saline or Ringers Lactate limited to 60ml/kg for first 72 hours

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Keith Corl, MD · Department of Pulmonary Critical Care Brown University

  • Mitchell Levy, MD · Department of Pulmonary Critical Care Brown University

  • Amy Palmisciano, RN, BSN · Department of Pulmonary Critical Care Brown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2018-03-30
Completion
2018-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137446 on ClinicalTrials.gov