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Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

Primary Purpose

Multiple Trauma

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

optimal resuscitation

About this trial

This is an interventional supportive care trial for Multiple Trauma

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

multiple trauma patients Adult patients

Exclusion Criteria:

cardiac renal chronic chest disease diabetic more than 3 years

Sites / Locations

Emad Zarief Kamel SaidRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

optimal resuscitation

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

serum level of lactate and its changes

as an index for tissue oxygenation

Secondary Outcome Measures

Kidney function

serum creatinine in mg/ dl and urine output/ hour

hemodynamic stability including pulse rate and mean arterial blood pressure

duration of stay in the critical care unit

Full Information

NCT ID

NCT02727946

First Posted

March 23, 2016

Last Updated

September 17, 2016

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02727946

Brief Title

Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

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 Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Trauma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

optimal resuscitation

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

optimal resuscitation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 hours

Title

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

Time Frame

6 hours

Title

serum level of lactate and its changes

Description

as an index for tissue oxygenation

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Kidney function

Description

serum creatinine in mg/ dl and urine output/ hour

Time Frame

72 hours

Title

hemodynamic stability including pulse rate and mean arterial blood pressure

Time Frame

72 hours

Title

duration of stay in the critical care unit

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: multiple trauma patients Adult patients Exclusion Criteria: cardiac renal chronic chest disease diabetic more than 3 years

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emad Zarief Kamel Said, MD

Phone

00201007046058

emadzarief@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emad Zarief Kamel Said, MD

Organizational Affiliation

Assiut University

Official's Role

Study Director

Facility Information:

Facility Name

Emad Zarief Kamel Said

City

Assiut

ZIP/Postal Code

71111

Country

Egypt

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

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