NCT01922960

Brief Summary

Predict the development of multiple organ failure in patients with trauma and severe burns.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

April 7, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

June 27, 2013

Last Update Submit

November 27, 2017

Conditions

BurnsTrauma

Keywords

traumamultiple organ dysfunction syndrome

Outcome Measures

Primary Outcomes (1)

  • dysfunctional capillary density correlates with development of multiple organ failure

    approximately 1 year to assess outcome measure

Study Arms (1)

micro-imaging

OTHER

Sublingual or subconjunctival micro-imaging of the microcirculation taken for 3 minute intervals at certain timepoints. Timepoints for burn/trauma subjects: Day0, Day1,Day2,Day6 \& Day7 Timepoints for general surgery population: post-induction, prior to resection, after resection,\& closing of surgical wound.

Other: micro-imaging

Interventions

micro-imagingOTHER

micro-imaging

micro-imaging

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe burns/trauma ages 19-80. Patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old

You may not qualify if:

  • Patients undergoing elective surgery \< 19 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

MeSH Terms

Conditions

BurnsWounds and InjuriesMultiple Organ Failure

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William O Richards, MD

    University of South Alabama, Department of Surgery

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair and Principle Investigator

Study Record Dates

First Submitted

June 27, 2013

First Posted

August 14, 2013

Study Start

April 7, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)