Renal Transplant Failure and RejectionNCT05753475
HOW DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANTATION?
An observational study of Renal Transplant Failure and Rejection and Hypotension, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of the researchers was to evaluate the adequacy of graft function in the postoperative period of patients who underwent renal transplantation and encountered hypotension in the intraoperative period. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplant Failure and Rejection, Hypotension
- What is being tested?
- renal transplantation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2023to Feb 2024
- How long will I take part?
- 1 Year
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients undergoing renal transplantation
Who may be able to join
- patients undergoing renal transplantation
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANT?
The aim of the researchers was to evaluate the adequacy of graft function in the postoperative period of patients who underwent renal transplantation and encountered hypotension in the intraoperative period.
- Being tested
- renal transplantation
- Medical subject headings
- Rejection, Psychology, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal transplantationOther
patients undergoing renal transplantation
| Study group | Role | What they receive |
|---|---|---|
| hypotension | Not described Receives: Other: renal transplantation | |
| normotension | Not described Receives: Other: renal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: baseline
Mean Arterial Pressure
Measured: baseline
Systolic Blood Pressure
Measured: during the surgery
Mean Arterial Pressure
Measured: during the surgery
graft function
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753475
- Sponsor's protocol ID
- E1-23-3249
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANT?
- ClinicalTrials.gov ID
- NCT05753475
- Acronym / sponsor ID
- E1-23-3249
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 3 Mar 2023 (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.
The aim of the researchers was to evaluate the adequacy of graft function in the postoperative period of patients who underwent renal transplantation and encountered hypotension in the intraoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypotension | – | Other: renal transplantation |
| normotension | – | Other: renal transplantation |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing renal transplantation
Key inclusion criteria (1 listed)
- patients undergoing renal transplantation
Key exclusion criteria (1 listed)
- patient refusal
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 |
|---|---|---|
| renal transplantationpatients undergoing renal transplantation | Other | hypotension, normotension |
Primary outcome
Systolic Blood Pressure
Time frame: baseline
Mean Arterial Pressure
Time frame: baseline
Systolic Blood Pressure
Time frame: during the surgery
Mean Arterial Pressure
Time frame: during the surgery
graft function
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Transplant Failure and Rejection and Hypotension, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 Mar 2023. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: baseline). The study lists 5 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 3 Mar 2023.