NCT01453270

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable sepsis

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

October 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2.3 years

First QC Date

October 12, 2011

Last Update Submit

September 23, 2014

Conditions

SepsisShock, Septic

Keywords

SepsisEmergency medicineCardiac outputStroke volumeLactate

Outcome Measures

Primary Outcomes (1)

  • Lactate clearance >20%

    Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.

    3 hours

Secondary Outcomes (1)

  • Total hospital cost

    At discharge, death or 28 days, whichever occurs earlier

Study Arms (2)

NICOM and PLR

EXPERIMENTAL

A systematic approach to resuscitation started in the ED and using a step-wise approach to optimize cardiac preload, afterload, and contractility, thus optimizing oxygen delivery to the tissues will be applied to the intervention group using the Non-Invasive Cardiac Output Monitor (NICOM) and passive leg-raising (PLR) maneuver.

Device: NICOM

Usual care

ACTIVE COMPARATOR
Other: Usual care

Interventions

NICOMDEVICE

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.

NICOM and PLR
Usual careOTHER

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.

Usual care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfillment of at least 2 systemic inflammatory response syndrome (SIRS) criteria
  • Suspected infection
  • Serum lactate ≥3mmol/L

You may not qualify if:

  • Age below 21 years
  • Known pregnancy
  • Prisoners
  • Do-not-attempt resuscitation status
  • Known severe aortic insufficiency or severe anatomic abnormalities of the thoracic aorta
  • Primary diagnosis of trauma, burns, active seizures, acute cerebral vascular accident, acute coronary syndrome, status asthmaticus, major cardiac arrhythmias, active gastrointestinal haemorrhage, seizure or drug overdose
  • Requirement for immediate surgery
  • Inability to do PLR (e.g. ankylosis of hip joint, severe sciatica)
  • Treating physician deems aggressive care unsuitable
  • Those unable to give informed consent and unable to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Win Sen Kuan, MBBS

    National University Health System, Singapore

    PRINCIPAL INVESTIGATOR

  • Irwani Ibrahim, MBBS

    National University Health System, Singapore

    PRINCIPAL INVESTIGATOR

  • Benjamin SH Leong, MBBS

    National University Health System, Singapore

    PRINCIPAL INVESTIGATOR

  • Malcolm Mahadevan, MBBS

    National University Health System, Singapore

    STUDY CHAIR

  • Yin Bun Cheung, PhD

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 17, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

SG(1)