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NCT Number: NCT05836922

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'anesthésie et réanimation adulte

Marseille, France

Location status: Recruiting

Location contact

Pierre MORA, MD

CONTACT

[email protected]

04 91 96 60 07

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of early postoperative acute renal failure up to the fifth postoperative day

    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).

Secondary outcomes

  1. Use of Extrarenal Purification

    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.

  2. Vital status

    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.

  3. maximum variation in serum creatinine

    Time frame: 5 days postoperative

    The maximum variation in serum creatinine between the fifth postoperative day and the patient's preoperative baseline value.

  4. average glomerular filtration rate

    Time frame: 5 days postoperative

    The average glomerular filtration rate for the first 5 days post-surgery, measured using the urine collection method.

  5. occurrence of primary graft dysfunction

    Time frame: 5 days postoperative

    The occurrence of primary graft dysfunction within the first 5 days post-operatively.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Mora

CONTACT

[email protected]

0491965537

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SO-AKI-TP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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