Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02727946
Other study ID # IRB00009902
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT02682550 - Danger Response in Polytrauma Patients N/A
Completed NCT03634215 - Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma
Completed NCT00872690 - Factors Affecting Return to Work Among OEF/OIF Veterans With Polytrauma N/A
Completed NCT01669577 - Independent Predictors of Mortality in Polytrauma Patients Phase 3
Recruiting NCT04588311 - ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients Phase 3
Terminated NCT00613392 - Antioxidant Supplementation in Trauma Patients Phase 3
Completed NCT02917694 - A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma
Recruiting NCT05386199 - The Role of Serotonin in Intensive Care Patients
Completed NCT03480555 - Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients N/A
Recruiting NCT03368092 - Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma Phase 3
Recruiting NCT01240291 - The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition Phase 3
Not yet recruiting NCT01074112 - Keller Prehospital Ultrasound Study N/A
Completed NCT00163826 - Spinal Clearance Study: Expediting the Spinal Clearance Process in the Major Trauma Patient Phase 4
Completed NCT05630222 - Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen Phase 3
Terminated NCT03489577 - The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients
Terminated NCT01477697 - Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients Phase 1/Phase 2
Completed NCT01373996 - Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal N/A
Completed NCT03154424 - Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients N/A
Recruiting NCT00622934 - Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients Phase 2
Recruiting NCT00459160 - A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients N/A