The Effect of Intraoperative Arterial Oxygen Pressures on Early Post-Operative Patient and Graft Survival in Living Donor Kidney Transplantation

NCT04420897 | Completed

• 1 other identifier: The effect of Pa02 in KT
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

We evaluated the prognostic role of the intraoperative arterial oxygen partial pressures (PaO2) on postoperative patient and graft survival in living donor kidney transplantations.

Conditions

Kidney Transplant; Complications; Hyperoxia; Graft Dysfunction

Outcome Measures

Primary Outcomes (3)

• Assessment of arterial blood gases with normoxia

  Approximately 1000 patients enrolled have living donor renal transplantation. After separation by study limitation of the accepted groups according to the PaO2 levels, graft functions and the patient's prognosis will be evaluated by enrolled data gained during the postoperative first month.

  Postoperative first following month

• Assessment of arterial blood gases with Moderate hyperoxemia

  Approximately 1000 patients enrolled have living donor renal transplantation. After separation by study limitation of the accepted groups according to the PaO2 levels, graft functions and the patient's prognosis will be evaluated by enrolled data gained during the postoperative first month.

  Postoperative first following month

• Assessment of arterial blood gases with Severe hyperoxemia

  Approximately 1000 patients enrolled have living donor renal transplantation. After separation by study limitation of the accepted groups according to the PaO2 levels, graft functions and the patient's prognosis will be evaluated by enrolled data gained during the postoperative first month.

  Postoperative first following month

Study Arms (3)

Normoxy: PaO2 = 80-120 mm Hg

Data collection explained below: Arterial blood samples from all groups shall be taken after induction, 5 minutes after graft perfusion, and end of surgery in the intraoperative period, in the operating room. The duration of the intensive care unit (ICU), the duration of mechanical ventilation in intensive care, Whether or not to re-intubate, hospital stay, intraoperative and postoperative laboratory data, immunosuppression regimen, postoperative complications (surgical site infection, ischemic vascular conditions, complications from respiratory) and interventions will be included for the study analysis. The survival of the patients will be enrolled, and the relationship between the obtained data and survival will be investigated. For early-stage graft survival, postoperatively; Data such as renal replacement therapy, the total amount of urine levels, creatinine values, presence of delayed graft function will be recorded.

Procedure: Arterial blood gas samples

Moderate hyperoxemia: PaO2 =120-200 mm Hg

Data collection explained below: Arterial blood samples from all groups shall be taken after induction, 5 minutes after graft perfusion, and end of surgery in the intraoperative period, in the operating room. The duration of the intensive care unit (ICU), the duration of mechanical ventilation in intensive care, Whether or not to re-intubate, hospital stay, intraoperative and postoperative laboratory data, immunosuppression regimen, postoperative complications (surgical site infection, ischemic vascular conditions, complications from respiratory) and interventions will be included for the study analysis. The survival of the patients will be enrolled, and the relationship between the obtained data and survival will be investigated. For early-stage graft survival, postoperatively; Data such as renal replacement therapy, the total amount of urine levels, creatinine values, presence of delayed graft function will be recorded.

Procedure: Arterial blood gas samples

Severe hyperoxemia: PaO2 >200 mm Hg

Data collection explained below: Arterial blood samples from all groups shall be taken after induction, 5 minutes after graft perfusion, and end of surgery in the intraoperative period, in the operating room. The duration of the intensive care unit (ICU), the duration of mechanical ventilation in intensive care, Whether or not to re-intubate, hospital stay, intraoperative and postoperative laboratory data, immunosuppression regimen, postoperative complications (surgical site infection, ischemic vascular conditions, complications from respiratory) and interventions will be included for the study analysis. The survival of the patients will be enrolled, and the relationship between the obtained data and survival will be investigated. For early-stage graft survival, postoperatively; Data such as renal replacement therapy, the total amount of urine levels, creatinine values, presence of delayed graft function will be recorded.

Procedure: Arterial blood gas samples

Interventions

Arterial blood gas samples PROCEDURE

Blood gases taken during the operation will be analyzed retrospectively. Whether these results have an effect on graft survival will be examined by reaching their records in the postoperative period.

Moderate hyperoxemia: PaO2 =120-200 mm Hg; Normoxy: PaO2 = 80-120 mm Hg; Severe hyperoxemia: PaO2 >200 mm Hg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We enrolled only 1000 adult living donor kidney transplantations closed files started from 1st of January 2017 to 1st of November 2019. The study conducted at the Department of Anesthesiology and Critical Care with the Department of General and Visceral Surgery Medical Center. All recipient surgical procedure was carried out by the same specialized transplantation surgeons and anesthesiologists after a positive vote of the local ethics committee for transplantation. Recipients with a history of myocardial infarction, chronic respiratory disease (bronchial asthma, COPD) were excluded from the study.

You may qualify if:

• Patients who had living donor kidney transplantation between January 2014 and June 2019 at Akdeniz University Faculty of Medicine Organ Transplant Center.

You may not qualify if:

• Patients with missing data
• Patients with a history of chronic heart failure or chronic respiratory disease (bronchial asthma, COPD).
• Presence of cadaveric donor kidney transplantation

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation

Antalya, 07059, Turkey (Türkiye)

Location

Related Publications (1)

• Dinc B, Yilmaz VT, Aycan IO, Kisaoglu A, Dandin O, Aydinli B, Hadimioglu N, Ertug Z. Effect of post-perfusion hyperoxemia on early graft function in renal transplant recipients: a retrospective observational cohort study. Ir J Med Sci. 2021 Nov;190(4):1539-1545. doi: 10.1007/s11845-020-02499-7. Epub 2021 Jan 4.

  PMID: 33398714 DERIVED

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bora Di̇nc, MD, Assist. Prof.

  Akdeniz University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: May 1, 2020
• Primary Completion: November 29, 2020
• Study Completion: December 1, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-12

Locations

TU (1)