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Trial record 15 of 671 for:    CARBON DIOXIDE AND arterial

Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

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ClinicalTrials.gov Identifier: NCT02727946
Recruitment Status : Unknown
Verified April 2016 by Emad Zarief , MD, Assiut University.
Recruitment status was:  Recruiting
First Posted : April 5, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, 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.

Condition or disease Intervention/treatment Phase
Multiple Trauma Other: optimal resuscitation Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. the difference between partial pressure of oxygen in arterial and venous blood [ Time Frame: 6 hours ]
  2. the difference between partial pressure of carbon dioxide in arterial and venous blood [ Time Frame: 6 hours ]
  3. serum level of lactate and its changes [ Time Frame: 6 hours ]
    as an index for tissue oxygenation


Secondary Outcome Measures :
  1. Kidney function [ Time Frame: 72 hours ]
    serum creatinine in mg/ dl and urine output/ hour

  2. hemodynamic stability including pulse rate and mean arterial blood pressure [ Time Frame: 72 hours ]
  3. duration of stay in the critical care unit [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • multiple trauma patients Adult patients

Exclusion Criteria:

  • cardiac renal chronic chest disease diabetic more than 3 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727946


Contacts
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Contact: Emad Zarief Kamel Said, MD 00201007046058 emadzarief@yahoo.com

Locations
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Egypt
Emad Zarief Kamel Said Recruiting
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Emad Zarief Kamel Said, MD Assiut University

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Responsible Party: Emad Zarief , MD, Lecturer of Anesthesia and critical care Medicine, Assiut University
ClinicalTrials.gov Identifier: NCT02727946     History of Changes
Other Study ID Numbers: IRB00009902
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Trauma
Wounds and Injuries