MedTrace Logo

Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial

NCT01453270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2014-09-25

No results posted yet for this study

Summary

The purpose of this study is to determine whether the use of a 3-hour protocol utilizing non-invasive hemodynamic optimization treatment strategy results in better outcome and lower hospital costs in patients who present with severe bloodstream infections to the Emergency Department (ED).

Conditions

Interventions

DEVICE

NICOM

Assessment of fluid responsiveness will be done using the non-invasive cardiac output monitor (NICOM) and passive leg-raising (PLR) maneuver to target mean arterial pressure of between 65mmHg and 90mmHg; and change in stroke volume index (SVI) less than 10%, prior to administration of fluid boluses.

OTHER

Usual care

Usual care is given at the clinician's discretion in accordance with current best practice. Standard treatment may involve treatment with intravenous fluids, and medications to support the blood pressure and heart.

Sponsors & Collaborators

  • Singapore Clinical Research Institute

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Win Sen Kuan, MBBS · National University Health System, Singapore

  • Irwani Ibrahim, MBBS · National University Health System, Singapore

  • Benjamin SH Leong, MBBS · National University Health System, Singapore

  • Malcolm Mahadevan, MBBS · National University Health System, Singapore

  • Yin Bun Cheung, PhD · Duke-NUS Graduate Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

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 NCT01453270 on ClinicalTrials.gov