Fluid Responsiveness in Early Post-kidney Transplantation PeriodCIVC-KTNCT06799299
Collapsibility Index of the Inferior Vena Cava and Kidney Transplantation
An observational study of Fluid Responsiveness in Early Post-kidney Transplantation Period, run by CHU de Reims at 1 site in France.
Trial summary
Delayed graft function following renal transplantation is common occurrence and is associated with an increased risk of acute rejection and chronic allograft nephropathy. Post transplant patients are usually hyperhydrated to optimize renal blood flow and thus graft function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness in Early Post-kidney Transplantation Period
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2025to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participation in the study will be offered to all eligible patients during the preoperative phase of renal transplantation in the nephrology intensive care unit of REIMS hospital. Eligibility will be confirmed based on clinical, biological and immunological assessments demonstrating the feasibility of the transplant. Patients will receive detailed information about the study's objectives and procedures through an information leaflet. Those who agree to participate will be included in the study. Each patient's participation will extend from Day 0 of the transplant procedure to Month 1post transplant. All patients requiring a post transplantation volume expansion will be included.
Who may be able to join
- Diagnosis of End-stage renal disease (ESRD)
- Hospitalization in the nephrology intensive care unit at Reims University Hospital
- Hospitalization due to renal transplantation
- Willingness to provide informed consent and participate in the study
- Receiving volume expansion following renal transplantation.
Who cannot join
- Inability to obtain high-quality ultrasound images
- Unavailability of Intra-vesical pressure and central venous pressure measurements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Damien JOLLY
Reims
Loïc LIEVRE, 03 26 78 46 94 ext. 0033, llievre@chu-reims.fr
About this study
Official title: Diagnostic Performance of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Early Post-kidney Transplantation Period
Delayed graft function following renal transplantation is common occurrence and is associated with an increased risk of acute rejection and chronic allograft nephropathy. Post transplant patients are usually hyperhydrated to optimize renal blood flow and thus graft function. However, cardiac failure to respond adequately to volume expansion can lead to renal venous congestion and visceral interstitial sodium and water overload, both of which are associated with the delayed kidney graft function. To our knowledge, no predictive index for fluid responsiveness has been evaluated in post-renal transplantation setting. In intensive care, the inferior vena cava variability index measured by transthoracic echocardiography (TTE) under standardized breathing conditions, is a simple, non-invasive and effective tool for predicting fluid responsiveness in patients hospitalized for sepsis. Applying this index in the post-renal transplantation period could potentially optimize early management and enhance the recovery of kidney graft function.
In this study, we aim to evaluate the diagnostic performance of the inferior vena cava variability index in predicting fluid responsiveness after renal transplantation. This is a monocentric, prospective, and observational study conducted in the nephrology intensive care unit at University Reims Hospital.
Read the detailed description
The study is a prospective, observational, single-center cohort (nephrology intensive care unit at University Reims Hospital) designed to evaluate the diagnostic performance of the Inferior Vena Cava Variability Index (IVCv) in predicting fluid responsiveness in post-kidney transplantation patients.
The study aims to decrease the number of patients delayed graft function and to optimize recovery of kidney function. Delayed graft function is a frequent complication occurring in 20-25% of kidney transplants. Delayed graft function increases the risk of acute rejection and chronic graft dysfunction. Fluid management is critical in the early postoperative period to optimize renal blood flow and graft function, but excessive fluid administration in non-responsive patients can lead to renal congestion and interstitial edema, negatively impacting graft recovery.
The IVCv, a simple and non-invasive echocardiographic index, assesses the diameter variability of the inferior vena cava induced by respiratory pressure changes. This index has been validated in septic patients to predict fluid responsiveness following volume expansion but has not yet been evaluated in the specific context of kidney transplantation. This study hypothesizes that IVCv could predict fluid responsiveness in this population, enabling tailored fluid management.
The primary objective of this study is therefore to determine the diagnostic performance of the inferior vena cava variability to predict fluid responsiveness in early post-kidney transplantation period.
Secondary objectives include:
- Evaluating the diagnostic performance of central venous pressure variability (CVPv) to predict fluid responsiveness in early post-kidney transplantation period.
- Identifying predictive markers of non-responsiveness to volume expansion.
- Assessing renal response to fluid responsiveness.
- Investigating associations between non-responsiveness, delayed graft function, and intra-abdominal pressure variations.
Key procedures involve transthoracic echocardiography (TTE) before and after fluid administration. Parameters such as IVCv, cardiac output, and central venous pressure will be systematically measured. Additional monitoring includes daily renal function markers, urine output, and extracellular hydration status during the first month post-transplantation.
The study will enroll 150 adult end-stage renal disease patients undergoing kidney transplantation at CHU Reims. Fluid responsiveness is defined as a ≥10% increase in cardiac output following a 500 mL crystalloid infusion. Non-responders are patients with <10% cardiac output improvement.
- Being tested
- No Intervention
- Keywords
- Inferior vena cava, Fluid responsiveness, Fluid overload, Delayed graft function, Kidney transplantation
- Medical subject headings
- Edema, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Responders | cardiac output increases by >10%. Receives: Other: No Intervention | |
| Non-responders | cardiac output increases by ≤10%. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior vena cava variability index (IVCv) and the cardiac output (to determine diagnostic performances of this index)
IVCv will be measured by echocardiography before the volume expansion Patients will be classified as responders if their cardiac output increases by > 10% after volume expansion, and in non-responders if not
Measured: Day 1
Secondary outcomes (4)
Central venous pressure variability index and the cardiac output (to determine diagnostic performances of this index)
Central venous pressure variability index before the volume expansion
Measured: Day 1
Predictive markers of non-responsiveness to volume expansion
Patients' characteristics at baseline and the cardiac output
Measured: Day 1
Renal response to fluid responsiveness
Changes in plasma creatinine levels, diuresis and intra-abdominal pressure after volume expansion
Measured: Day 30
Intra-abdominal pressure variations
Associations between non-responsiveness, delayed graft function, and intra-abdominal pressure variations
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Responsiveness in Early Post-kidney Transplantation PeriodStudies 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
- 150 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
- NCT06799299
- Sponsor's protocol ID
- PS25002
- Acronym
- CIVC-KT
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Early Post-kidney Transplantation Period
- ClinicalTrials.gov ID
- NCT06799299
- Acronym / sponsor ID
- CIVC-KT / PS25002
- Keywords
- Inferior vena cava, Fluid responsiveness, Fluid overload, Delayed graft function, Kidney transplantation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 29 Jan 2025 (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.
Delayed graft function following renal transplantation is common occurrence and is associated with an increased risk of acute rejection and chronic allograft nephropathy. Post transplant patients are usually hyperhydrated to optimize renal blood flow and thus graft function. However, cardiac failure to respond adequately to volume expansion can lead to renal venous congestion and visceral interstitial sodium and water overload, both of which are associated with the delayed kidney graft function. To our knowledge, no predictive index for fluid responsiveness has been evaluated in post-renal transplantation setting. In intensive care, the inferior vena cava variability index measured by transthoracic echocardiography (TTE) under standardized breathing conditions, is a simple, non-invasive and effective tool for predicting fluid responsiveness in patients hospitalized for sepsis. Applying this index in the post-renal transplantation period could potentially optimize early management and enhance the recovery of kidney graft function.
In this study, we aim to evaluate the diagnostic performance of the inferior vena cava variability index in predicting fluid responsiveness after renal transplantation. This is a monocentric, prospective, and observational study conducted in the nephrology intensive care unit at University Reims Hospital.
Detailed description
The study is a prospective, observational, single-center cohort (nephrology intensive care unit at University Reims Hospital) designed to evaluate the diagnostic performance of the Inferior Vena Cava Variability Index (IVCv) in predicting fluid responsiveness in post-kidney transplantation patients.
The study aims to decrease the number of patients delayed graft function and to optimize recovery of kidney function. Delayed graft function is a frequent complication occurring in 20-25% of kidney transplants. Delayed graft function increases the risk of acute rejection and chronic graft dysfunction. Fluid management is critical in the early postoperative period to optimize renal blood flow and graft function, but excessive fluid administration in non-responsive patients can lead to renal congestion and interstitial edema, negatively impacting graft recovery.
The IVCv, a simple and non-invasive echocardiographic index, assesses the diameter variability of the inferior vena cava induced by respiratory pressure changes. This index has been validated in septic patients to predict fluid responsiveness following volume expansion but has not yet been evaluated in the specific context of kidney transplantation. This study hypothesizes that IVCv could predict fluid responsiveness in this population, enabling tailored fluid management.
The primary objective of this study is therefore to determine the diagnostic performance of the inferior vena cava variability to predict fluid responsiveness in early post-kidney transplantation period.
Secondary objectives include:
- Evaluating the diagnostic performance of central venous pressure variability (CVPv) to predict fluid responsiveness in early post-kidney transplantation period.
- Identifying predictive markers of non-responsiveness to volume expansion.
- Assessing renal response to fluid responsiveness.
- Investigating associations between non-responsiveness, delayed graft function, and intra-abdominal pressure variations.
Key procedures involve transthoracic echocardiography (TTE) before and after fluid administration. Parameters such as IVCv, cardiac output, and central venous pressure will be systematically measured. Additional monitoring includes daily renal function markers, urine output, and extracellular hydration status during the first month post-transplantation.
The study will enroll 150 adult end-stage renal disease patients undergoing kidney transplantation at CHU Reims. Fluid responsiveness is defined as a ≥10% increase in cardiac output following a 500 mL crystalloid infusion. Non-responders are patients with <10% cardiac output improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | – | Other: No Interventioncardiac output increases by >10%. |
| Non-responders | – | Other: No Interventioncardiac output increases by ≤10%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in the study will be offered to all eligible patients during the preoperative phase of renal transplantation in the nephrology intensive care unit of REIMS hospital. Eligibility will be confirmed based on clinical, biological and immunological assessments demonstrating the feasibility of the transplant. Patients will receive detailed information about the study's objectives and procedures through an information leaflet. Those who agree to participate will be included in the study. Each patient's participation will extend from Day 0 of the transplant procedure to Month 1post transplant. All patients requiring a post transplantation volume expansion will be included.
Key inclusion criteria (5 listed)
- Diagnosis of End-stage renal disease (ESRD)
- Hospitalization in the nephrology intensive care unit at Reims University Hospital
- Hospitalization due to renal transplantation
- Willingness to provide informed consent and participate in the study
- Receiving volume expansion following renal transplantation.
Key exclusion criteria (2 listed)
- Inability to obtain high-quality ultrasound images
- Unavailability of Intra-vesical pressure and central venous pressure measurements
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 |
|---|---|---|
| No InterventionNo intervention | Other | Non-responders, Responders |
Primary outcome
Inferior vena cava variability index (IVCv) and the cardiac output (to determine diagnostic performances of this index)
Time frame: Day 1
IVCv will be measured by echocardiography before the volume expansion Patients will be classified as responders if their cardiac output increases by > 10% after volume expansion, and in non-responders if not
4 secondary outcomes
Central venous pressure variability index and the cardiac output (to determine diagnostic performances of this index)
Time frame: Day 1
Predictive markers of non-responsiveness to volume expansion
Time frame: Day 1
Renal response to fluid responsiveness
Time frame: Day 30
Intra-abdominal pressure variations
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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.
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 Fluid Responsiveness in Early Post-kidney Transplantation Period, 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 5 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: opening soon, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loïc LIEVRE (03 26 78 46 94 ext. 0033, llievre@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inferior vena cava variability index (IVCv) and the cardiac output (to determine diagnostic performances of this index) (time frame: Day 1). 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 Jan 2025.