NCT05836922 Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study
| NCT ID | NCT05836922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Lung Transplant; Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-23 |
| Primary Completion | 2026-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-03-23 with a primary completion date of 2026-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Complications after lung transplantation are almost ubiquitous, among which postoperative acute renal failure may represent more than 50% of lung transplant patients and require extrarenal purification in 5 to 13% of cases. Multiple factors are associated with postoperative acute renal failure. These factors can be classified into preoperative, intraoperative, and postoperative factors. While some postoperative complications are explained by donor and recipient factors, the literature suggests that certain intraoperative events represent modifiable or avoidable risk factors that could be targeted by therapeutic interventions to reduce the risk of postoperative acute renal failure. Some of these factors (intraoperative hemodynamic instability, significant bleeding or hypoxemia) can generate renal hypoxic aggression, alone or in combination. However, to date, there is no validated tool available at the patient's bedside during surgery to detect renal hypoxia or guide interventions to restore renal perfusion during surgery. Yet, as recent recommendations suggest, intraoperative renal protection is an important axis for improving the outcome of lung transplant patients, to the extent that the recommendations of Marczin et al. recommend the establishment of a renal prevention protocol for each patient. Without a tool to guide this plan intraoperatively, anesthesia teams can't establish a renal prevention protocol. This research aims to establish whether renal NIRS is a reliable tool for monitoring intraoperative renal hypoxic aggression predictive of postoperative renal failure. Near-infrared spectroscopy (NIRS) is an optical technology that allows non-invasive measurement of tissue oxygen saturation. This technique is commonly used for intraoperative monitoring of cerebral perfusion in adults and children. Some studies have shown that regional renal oxygen saturation (renal rSO2) measured by NIRS during aortic-coronary bypass surgery under extracorporeal circulation (ECC) is correlated with renal venous oxygen saturation measured by catheterization. It is also associated with the risk of postoperative acute renal failure in patients undergoing cardiac surgery under ECC. However, there are no equivalent data in lung transplant patients, who frequently present with postoperative acute renal failure. In the available literature, no clear threshold of renal desaturation has been established. Because it is assumed that the depth of renal desaturation can be particularly deleterious, in addition to desaturation time, the investigator have chosen to retain in this project the integral of time and magnitude spent under a renal desaturation threshold, aggregated into a renal hypoxia index, during the intraoperative period. The primary objective of this research is to demonstrate the usefulness of measuring the intraoperative renal hypoxia index in predicting the risk of early postoperative acute renal failure
Eligibility Criteria
Inclusion Criteria: * patient undergoing a lung transplant (mono or bi-transplantation) * Age \>= 18 years * Affiliated to the French social security system Exclusion Criteria: * Renal anatomical abnormality likely to induce a misleading NIRS signal: single kidney, polycystic kidney disease. * Expression of opposition to participation in the research protocol. * Hyperbilurbinemia \> 17mmol/l * Preoperative Extra Corporeal Membran Oxygenation (ECMO). * Preoperative mechanical ventilation
Contact & Investigator
François CREMIEUX
STUDY DIRECTOR
Assistance Publique Hopitaux De Marseille
Frequently Asked Questions
Who can join the NCT05836922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Transplant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05836922 currently recruiting?
Yes, NCT05836922 is actively recruiting participants. Contact the research team at pierre.mora@ap-hm.fr for enrollment information.
Where is the NCT05836922 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT05836922 clinical trial?
NCT05836922 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is François CREMIEUX at Assistance Publique Hopitaux De Marseille. The trial plans to enroll 80 participants.