Multiple TraumaNCT02727946
Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients
A study testing optimal resuscitation in people with Multiple Trauma, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Multiple Trauma
- What is being tested?
- optimal resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- multiple trauma patients Adult patients
Who cannot join
- cardiac renal chronic chest disease diabetic more than 3 years
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emad Zarief Kamel Said
Asyut, Asyut Governorate, 71111
About this study
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
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.
Read the 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).
- Conditions
- Multiple Trauma
- Being tested
- optimal resuscitation
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimal resuscitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| optimal resuscitation | Other | 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 Receives: Other: optimal resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference between partial pressure of oxygen in arterial and venous blood
Measured: 6 hours
the difference between partial pressure of carbon dioxide in arterial and venous blood
Measured: 6 hours
serum level of lactate and its changes
as an index for tissue oxygenation
Measured: 6 hours
Secondary outcomes (3)
Kidney function
serum creatinine in mg/ dl and urine output/ hour
Measured: 72 hours
hemodynamic stability including pulse rate and mean arterial blood pressure
Measured: 72 hours
duration of stay in the critical care unit
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
- Investigators
- Emad Zarief Kamel Said, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727946
- Sponsor's protocol ID
- IRB00009902
- Status last verified
- Apr 2016
- First submitted
- 23 Mar 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02727946
- Acronym / sponsor ID
- IRB00009902
- Conditions
- Multiple Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| optimal resuscitation | Other | Other: optimal resuscitationThis 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- multiple trauma patients Adult patients
Key exclusion criteria (1 listed)
- cardiac renal chronic chest disease diabetic more than 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optimal resuscitationoptimal 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 | Other | optimal resuscitation |
Primary outcome
the difference between partial pressure of oxygen in arterial and venous blood
Time frame: 6 hours
the difference between partial pressure of carbon dioxide in arterial and venous blood
Time frame: 6 hours
serum level of lactate and its changes
Time frame: 6 hours
as an index for tissue oxygenation
3 secondary outcomes
Kidney function
Time frame: 72 hours
hemodynamic stability including pulse rate and mean arterial blood pressure
Time frame: 72 hours
duration of stay in the critical care unit
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Multiple Trauma
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingPhase 2/3
Valproic AcId for Traumatic BRAin INjury Trial
Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Zarief Kamel Said, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optimal resuscitation in people with Multiple Trauma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emad Zarief Kamel Said, MD (00201007046058, emadzarief@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference between partial pressure of oxygen in arterial and venous blood (time frame: 6 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.