Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

Multiple Trauma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02727946
• Other study ID #: IRB00009902
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2016
• Last updated: September 17, 2016
• Start date: May 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2016
• Source: Assiut University
• Contact: Emad Zarief Kamel Said, MD
• Phone: 00201007046058
• Email: emadzarief[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• multiple trauma patients Adult patients

Exclusion Criteria:

• cardiac renal chronic chest disease diabetic more than 3 years

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference between partial pressure of oxygen in arterial and venous blood		6 hours	No
Primary	the difference between partial pressure of carbon dioxide in arterial and venous blood		6 hours	No
Primary	serum level of lactate and its changes	as an index for tissue oxygenation	6 hours	No
Secondary	Kidney function	serum creatinine in mg/ dl and urine output/ hour	72 hours	No
Secondary	hemodynamic stability including pulse rate and mean arterial blood pressure		72 hours	No
Secondary	duration of stay in the critical care unit		72 hours	No