Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

Not Applicable

• Conditions: Multiple Trauma
• Interventions: Other: optimal resuscitation

• Registration Number: NCT02727946
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study First Submitted: 2016-03-23
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-05
• Study Start: 2016-05
• Last Update Submitted: 2016-09-17
• Last Update Posted: 2016-09-20
• Primary Completion: 2017-09
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• multiple trauma patients Adult patients

Exclusion Criteria

• cardiac renal chronic chest disease diabetic more than 3 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
optimal resuscitation	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

Primary Outcome Measures

Name	Time	Method
the difference between partial pressure of oxygen in arterial and venous blood	6 hours
serum level of lactate and its changes	6 hours	as an index for tissue oxygenation
the difference between partial pressure of carbon dioxide in arterial and venous blood	6 hours

Secondary Outcome Measures

Name	Time	Method
Kidney function	72 hours	serum creatinine in mg/ dl and urine output/ hour
duration of stay in the critical care unit	72 hours
hemodynamic stability including pulse rate and mean arterial blood pressure	72 hours

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt