NCT02727946

Brief Summary

Early intervention and resuscitation based upon a lot of clinical, laboratory findings make a big difference regarding outcome in poly trauma patients, the study uses the dynamic lactate change and the difference between arterial and venous CO2, oxygen tension or content as indicators for tissue perfusion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

March 23, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

March 23, 2016

Last Update Submit

September 17, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • the difference between partial pressure of oxygen in arterial and venous blood

    6 hours

  • the difference between partial pressure of carbon dioxide in arterial and venous blood

    6 hours

  • serum level of lactate and its changes

    as an index for tissue oxygenation

    6 hours

Secondary Outcomes (3)

  • Kidney function

    72 hours

  • hemodynamic stability including pulse rate and mean arterial blood pressure

    72 hours

  • duration of stay in the critical care unit

    72 hours

Study Arms (1)

optimal resuscitation

OTHER

This group of multiple trauma patients will be resuscitated with crystalloids, analgesics, blood products as needed. Then follow up of the difference between arterial and venous CO2 to difference between arterial and venous oxygen tension, serum lactate, renal function, other organ affection along over the short hospital stay period

Other: optimal resuscitation

Interventions

optimal resuscitation to achieve mean arterial blood pressure above 65 mmHG , Central venous pressure more than 8 mmHg , urine out put more than 0.5 ml /Kg/hour

optimal resuscitation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • multiple trauma patients Adult patients

You may not qualify if:

  • cardiac renal chronic chest disease diabetic more than 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, Asyut Governorate, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Emad Zarief Kamel Said, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Emad Zarief Kamel Said, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and critical care Medicine

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 5, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

September 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations