Service d'anesthésie et réanimation adulte
Marseille, France
Location status: Recruiting
NCT Number: NCT05836922
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Marseille, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 5 days postoperative
The 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.
Time frame: 5 days postoperative
Any 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.
Time frame: 5 days postoperative
The maximum variation in serum creatinine between the fifth postoperative day and the patient's preoperative baseline value.
Time frame: 5 days postoperative
The average glomerular filtration rate for the first 5 days post-surgery, measured using the urine collection method.
Time frame: 5 days postoperative
The occurrence of primary graft dysfunction within the first 5 days post-operatively.
Contact information is provided by the study sponsor or research team.
Assistance Publique Hopitaux De Marseille
Other
Acronym: SO-AKI-TP
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