Liver Transplantationco2gapNCT03374579
co2 Gap and co2/o2 Ratio in Liver Transplant Patients
A study testing Fluid challenge in people with Liver Transplantation, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
finding surrogate to co to trace the effect of preload challenge would make the test more applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be used to detect FR after mini fluid challenge and fluid bolts . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Fluid challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Jun 2017to 12 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients post liver transplantation
- serum lactate >2mmol/L
Who cannot join
- age less than 18 years
- patients with fulminant liver failure.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo University Medical School
Cairo, 11511
Ahmed m Mukhtar, professor, 01114208444 ext. 002, ahmed.mukhtar@kasralainy.edu.eg
Hassan kh Nagy, professor, 01223634792 ext. 002, hknagi@hotmail.com
- Recruiting
Kasralainy hospital
Cairo, 11562
Ahmed Mukhtar, Professor, 01114208444, Ahmed.mukhtar@kasralainy.edu.eg
Hassan Khaled, Professor, 01223634792, hknagi@hotmail.com
About this study
Official title: Use of the Venoarterial Carbon Dioxide Gap and Arteriovenous Oxygen Content to Guide the Resuscitation in the Liver Transplant Patients
finding surrogate to co to trace the effect of preload challenge would make the test more applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be used to detect FR after mini fluid challenge and fluid bolts .
Read the detailed description
use of carbon dioxide gap and arterio venous oxygen content to trace the effect of preload challenge by giving via a specific venous line , first 150 ml is infused over one minute, after stroke volume at one minute measure the remaining 350 ml is infused over 14 minutes at constant rate , the fluid challenge performed with albumin 5% , fluid responsiveness is an increase in stroke volume by 15% after infusion of 500ml albumin 5%.
Objectives is to investigate the ability of VA-co2 gap and gap/ ratio to predict the hemodynamic response to mini fluid challenge, and to compare the validity of VA-co2 gap and gap/ratio with svo2 for prediction of fluid responsiveness.
- Conditions
- Liver Transplantation
- Being tested
- Fluid challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeDiagnostic test
Fluid challenge and measure change in co2 gap
| Study group | Role | What they receive |
|---|---|---|
| CO2 gap | Experimental | The patients will receive fluid bolus and observe changes in co2 gap and gap/ ratio in them. Receives: Diagnostic Test: Fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
co2gap
Difference between arterial and venous co2 gap
Measured: 30 minuets after fluid bolus
Secondary outcomes (1)
Stroke volume
Stroke volume assessed by cardiometry
Measured: Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start12 Jun 2017
- Primary completion12 May 2018 (estimated)
- Study completion12 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fluid challenge with assessment of change of co2 gap
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mukhtar, Kasr El Aini Hospital
- Investigators
- Ahmed m Mukhtar, professor, Principal investigator, kasrelainy medical school,cairo university,cairo,egyptHassan kh Nagi, professor, Study chair, kasrelainy medical school,cairo university,cairo,egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374579
- Sponsor's protocol ID
- N-60-2017
- Acronym
- co2gap
- Status last verified
- Mar 2018
- First submitted
- 11 Dec 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Venoarterial Carbon Dioxide Gap and Arteriovenous Oxygen Content to Guide the Resuscitation in the Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT03374579
- Acronym / sponsor ID
- co2gap / N-60-2017
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 May 2018 (estimated)
- Study completion
- 12 Sep 2018 (estimated)
- First posted
- 15 Dec 2017 (actual)
- 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.
finding surrogate to co to trace the effect of preload challenge would make the test more applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be used to detect FR after mini fluid challenge and fluid bolts .
Detailed description
use of carbon dioxide gap and arterio venous oxygen content to trace the effect of preload challenge by giving via a specific venous line , first 150 ml is infused over one minute, after stroke volume at one minute measure the remaining 350 ml is infused over 14 minutes at constant rate , the fluid challenge performed with albumin 5% , fluid responsiveness is an increase in stroke volume by 15% after infusion of 500ml albumin 5%.
Objectives is to investigate the ability of VA-co2 gap and gap/ ratio to predict the hemodynamic response to mini fluid challenge, and to compare the validity of VA-co2 gap and gap/ratio with svo2 for prediction of fluid responsiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fluid challenge with assessment of change of co2 gap
| Arm | Type | Receives |
|---|---|---|
| CO2 gap | Experimental | Diagnostic Test: Fluid challengeThe patients will receive fluid bolus and observe changes in co2 gap and gap/ ratio in them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients post liver transplantation
- serum lactate >2mmol/L
Key exclusion criteria (2 listed)
- age less than 18 years
- patients with fulminant liver failure.
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 |
|---|---|---|
| Fluid challengeFluid challenge and measure change in co2 gap | Diagnostic test | CO2 gap |
Primary outcome
co2gap
Time frame: 30 minuets after fluid bolus
Difference between arterial and venous co2 gap
1 secondary outcome
Stroke volume
Time frame: Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Ahmed m Mukhtar, professor principal investigator
kasrelainy medical school,cairo university,cairo,egypt
Hassan kh Nagi, professor study chair
kasrelainy medical school,cairo university,cairo,egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid challenge in people with Liver Transplantation, run by Kasr El Aini Hospital at 2 sites 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 2 inclusion and 2 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ahmed m Mukhtar, Professor (+0220111420844, Ahmed.mukhtar@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
co2gap (time frame: 30 minuets after fluid bolus). 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 29 Mar 2018.