Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02727946
Collaborator
(none)
40
1
1
20
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: optimal resuscitation
N/A

Detailed Description

Poly trauma patients have high incidence of mortality and morbidity in spite of improvements and advances in facilities. However, no doubt that early resuscitation and interventions make a big difference upon the overall outcome.

A lot of methods, indices, laboratory and biomarkers have been utilized to evaluate the progress and quality of resuscitation and the early hospital interventions in such group of critically ill patients including central venous pressures, urine output, mixed venous oxygen saturation, and gastric tonometry. Most of recent means focus upon the regional tissue perfusion rather than global, however some researches have tried the difference between arterial and venous CO2,oxygen tension or content ( Pv -a co2& Pa -v O2 ) in addition to dynamic changes in lactate(3) as predictors for tissue perfusion in sepsis patients after establishment of sepsis campaign (bundle).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Central Venous-arterial Carbon Dioxide Pressure Difference in Correlation to Dynamic Changes of Serum Lactate as an Indicator of Tissue Perfusion in Polytruama Patients
Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: optimal resuscitation

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
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

Outcome Measures

Primary Outcome Measures

  1. the difference between partial pressure of oxygen in arterial and venous blood [6 hours]

  2. the difference between partial pressure of carbon dioxide in arterial and venous blood [6 hours]

  3. serum level of lactate and its changes [6 hours]

    as an index for tissue oxygenation

Secondary Outcome Measures

  1. Kidney function [72 hours]

    serum creatinine in mg/ dl and urine output/ hour

  2. hemodynamic stability including pulse rate and mean arterial blood pressure [72 hours]

  3. duration of stay in the critical care unit [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • multiple trauma patients Adult patients
Exclusion Criteria:
  • cardiac renal chronic chest disease diabetic more than 3 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emad Zarief Kamel Said Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Emad Zarief Kamel Said, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emad Zarief , MD, Lecturer of Anesthesia and critical care Medicine, Assiut University
ClinicalTrials.gov Identifier:
NCT02727946
Other Study ID Numbers:
  • IRB00009902
First Posted:
Apr 5, 2016
Last Update Posted:
Sep 20, 2016
Last Verified:
Apr 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2016