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Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study

Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05836922
Acronym
SO-AKI-TP
Enrollment
80
Registered
2023-05-01
Start date
2024-03-23
Completion date
2026-09-28
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Lung Transplant; Complications

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

Interventions

None listed

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of early postoperative acute renal failure up to the fifth postoperative day5 days postoperativeOccurrence of early postoperative chronic kidney injury up to the fifth postoperative day, as defined by KDIGO (KDIGO stage 1 or higher).

Secondary

MeasureTime frameDescription
Use of Extrarenal Purification5 days postoperativeThe use of Extrarenal Purification before the end of the initial hospitalization will be collected; for deceased subjects who had renal failure prior to their death (and who therefore might have required Extrarenal Purification had they survived), we will consider that there was no use of Extrarenal Purification.
Vital status5 days postoperativeAny subject who died during the initial hospitalization will be recorded, while the others will be defined as alive at the end of the initial hospitalization.
maximum variation in serum creatinine5 days postoperativeThe maximum variation in serum creatinine between the fifth postoperative day and the patient's preoperative baseline value.
average glomerular filtration rate5 days postoperativeThe average glomerular filtration rate for the first 5 days post-surgery, measured using the urine collection method.
occurrence of primary graft dysfunction5 days postoperativeThe occurrence of primary graft dysfunction within the first 5 days post-operatively.

Countries

France

Contacts

CONTACTPierre Mora
pierre.mora@ap-hm.fr0491965537
STUDY_DIRECTORFrançois CREMIEUX

Assistance Publique Hopitaux De Marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026