Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

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

NCT05836922 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-03-23
Last updated
2026-02-23

Condition(s) studied

Lung Transplant; ComplicationsAcute Kidney Injury

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Occurrence of early postoperative acute renal failure up to the fifth postoperative day — 5 days postoperative
    Occurrence of early postoperative chronic kidney injury up to the fifth postoperative day, as defined by KDIGO (KDIGO stage 1 or higher).

Trial sites (1)

FacilityCityRegionStatus
Service d'anesthésie et réanimation adulte Marseille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05836922 on ClinicalTrials.gov ↗ ← All trials in France