Intraabdominal HypertensionKITIVNCT03478176
Intraabdominal Hypertension After Kidney Transplantation
An observational study of Intraabdominal Hypertension and Kidney Transplantation, run by CHU de Reims at 1 site in France.
Trial summary
Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraabdominal Hypertension, Kidney Transplantation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 May 2017to 8 Nov 2019
- Phase
- Observational
- 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
Study population: Patients with chronic kidney disease undergoing kidney transplantation in University Hospital of Reims (France)
Who may be able to join
- End stage chronic kidney disease ;
- Hospitalized in intensive care of nephrology unit in University Hospital of Reims (France) during study period ;
- Undergoing kidney transplantation ;
- Accepting to participate.
Who cannot join
- Minor ;
- Protected by the law.
Trial locations and contacts
1 site in 1 country.
Vincent DUPONT contact
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Alexandre DEBRUMETZ, adebrumetz@chu-reims.fr
About this study
Official title: Intraabdominal Hypertension After Kidney Transplantation : Incidence and Associated Factors
Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury is the most frequent and described complication of IAH condition.
Patients undergoing kidney transplantation have several risk factors to develop IAH. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.
We aim to study IAH incidence, associated factors and impact on renal function recovery in post kidney transplantation period.
Read the detailed description
Intraabdominal hypertension (IAH) is a frequent and severe condition affecting 30 to 54% of intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IAH is defined by IVP elevation above 12mmHg. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury (AKI)is the most frequent and described complication of IAH condition. IAH related AKI traduces renal hypoperfusion and its severity seems to correlate with IVP levels.
Patients undergoing kidney transplantation have several risk factors to develop IAH : abdominal wall surgery, acidosis and hypervolemic resuscitation. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.
We aim to study IAH incidence in post kidney transplantation period. Thus, we want to identify associated factors with IAH development in this context. We also aim to correlate IVP early evolution with extra-cellular hydration status evolution. Finally, impact of IAH on renal function recovery will be investigated.
Presupposing that 50 kidney transplantations per year will take place in University Hospital of Reims (France), we attend to include about 100 patients in this study. With a prevalence of at least 30% of IAH prevalence (as reported in intensive care units cohorts), enrollment of 100 patients will permit to estimate IAH prevalence with a 9% precision (with a 95%IC).
- Keywords
- Intraabdominal hypertension, Kidney transplantation
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraabdominal hypertension Intraabdominal pressure
Intraabdominal pressure equal or more than 12 mmHg for at least 2 measures spaced less than 24 hours. Intraabdominal pressure will be evaluated every 8 hours during the 5 days after transplantation, using UnometerTM AbdopressureTM system
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 May 2017
- Primary completion8 May 2019 (estimated)
- Study completion8 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraabdominal HypertensionStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478176
- Sponsor's protocol ID
- PZ17048
- Acronym
- KITIV
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dupont V, Debrumetz A, Leguillou A, Morland D, Wynckel A, Colosio C, Mokri L, Schvartz B, Vuiblet V, Larre S, Barbe C, Rieu P. Intra-abdominal hypertension in early post-kidney transplantation period is associated with impaired graft function. Nephrol Dial Transplant. 2020 Sep 1;35(9):1619-1628. doi: 10.1093/ndt/gfaa104.
PubMed 32678426
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraabdominal Hypertension After Kidney Transplantation : Incidence and Associated Factors
- ClinicalTrials.gov ID
- NCT03478176
- Acronym / sponsor ID
- KITIV / PZ17048
- Keywords
- Intraabdominal hypertension, Kidney transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 8 May 2019 (estimated)
- Study completion
- 8 Nov 2019 (estimated)
- First posted
- 27 Mar 2018 (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.
Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury is the most frequent and described complication of IAH condition.
Patients undergoing kidney transplantation have several risk factors to develop IAH. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.
We aim to study IAH incidence, associated factors and impact on renal function recovery in post kidney transplantation period.
Detailed description
Intraabdominal hypertension (IAH) is a frequent and severe condition affecting 30 to 54% of intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IAH is defined by IVP elevation above 12mmHg. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury (AKI)is the most frequent and described complication of IAH condition. IAH related AKI traduces renal hypoperfusion and its severity seems to correlate with IVP levels.
Patients undergoing kidney transplantation have several risk factors to develop IAH : abdominal wall surgery, acidosis and hypervolemic resuscitation. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.
We aim to study IAH incidence in post kidney transplantation period. Thus, we want to identify associated factors with IAH development in this context. We also aim to correlate IVP early evolution with extra-cellular hydration status evolution. Finally, impact of IAH on renal function recovery will be investigated.
Presupposing that 50 kidney transplantations per year will take place in University Hospital of Reims (France), we attend to include about 100 patients in this study. With a prevalence of at least 30% of IAH prevalence (as reported in intensive care units cohorts), enrollment of 100 patients will permit to estimate IAH prevalence with a 9% precision (with a 95%IC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease undergoing kidney transplantation in University Hospital of Reims (France)
Key inclusion criteria (4 listed)
- End stage chronic kidney disease ;
- Hospitalized in intensive care of nephrology unit in University Hospital of Reims (France) during study period ;
- Undergoing kidney transplantation ;
- Accepting to participate.
Key exclusion criteria (2 listed)
- Minor ;
- Protected by the law.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraabdominal hypertension Intraabdominal pressure
Time frame: day 5
Intraabdominal pressure equal or more than 12 mmHg for at least 2 measures spaced less than 24 hours. Intraabdominal pressure will be evaluated every 8 hours during the 5 days after transplantation, using UnometerTM AbdopressureTM system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Derived from this study: PubMed 32678426Dupont V, Debrumetz A, Leguillou A, Morland D, Wynckel A, Colosio C, Mokri L, Schvartz B, Vuiblet V, Larre S, Barbe C, Rieu P. Intra-abdominal hypertension in early post-kidney transplantation period is associated with impaired graft function. Nephrol Dial Transplant. 2020 Sep 1;35(9):1619-1628. doi: 10.1093/ndt/gfaa104.
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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.
Vincent DUPONT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Hypertension and Kidney Transplantation, run by CHU de Reims at 1 site in France.
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 4 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 27 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 1 site in France. 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 Alexandre DEBRUMETZ (0326787641 ext. 0033, adebrumetz@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraabdominal hypertension Intraabdominal pressure (time frame: day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03478176, which also lists 1 linked publication.
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 27 Mar 2018.