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Lung Transplant; ComplicationsSO-AKI-TPNCT05836922

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

An observational study of Lung Transplant; Complications and Acute Kidney Injury, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
80 participants
Where
1 siteFrance
Study dates
23 Mar 2024to 28 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing a lung transplantation.

Who may be able to join

  • patient undergoing a lung transplant (mono or bi-transplantation)
  • Age >= 18 years
  • Affiliated to the French social security system

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Service d'anesthésie et réanimation adulte

    Marseille

    Pierre MORA, MD, 04 91 96 60 07, pierre.mora@ap-hm.fr

    Recruiting

Other trials in France

About this 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.

Read more

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

Medical subject headings
Acute Kidney Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Occurrence of early postoperative chronic kidney injury up to the fifth postoperative day, as defined by KDIGO (KDIGO stage 1 or higher).

    Measured: 5 days postoperative

Secondary outcomes (5)
  1. Use of Extrarenal Purification

    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.

    Measured: 5 days postoperative

  2. Vital status

    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.

    Measured: 5 days postoperative

  3. maximum variation in serum creatinine

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

    Measured: 5 days postoperative

  4. average glomerular filtration rate

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

    Measured: 5 days postoperative

  5. occurrence of primary graft dysfunction

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

    Measured: 5 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start23 Mar 2024
  3. Primary completion28 Sep 2026 (estimated)
  4. Study completion28 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836922
Sponsor's protocol ID
RCAPHM23_0007
Acronym
SO-AKI-TP
Status last verified
Feb 2026
First submitted
19 Apr 2023
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplant; Complications and Acute Kidney Injury, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pierre Mora (0491965537, pierre.mora@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of early postoperative acute renal failure up to the fifth postoperative day (time frame: 5 days postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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