Renal Oxygen Saturation and Its Association With Acute Renal Injury

NCT03608956 | Withdrawn

• 1 other identifier: 09.2017.642
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-operative renal dysfunction is a major mortality and morbidity cause following cardiac and major vascular surgery. Although several intra-operative strategies are proposed for better outcomes, no effective and fast resulting test is available to be done in operating rooms to assess renal functions. Urine and blood markers as serum creatinine, urine output, fractional excretion of sodium and urea are used for early diagnosis of acute renal injury. Near infrared spectroscopy (NIRS) assesses tissue oxygenation especially cerebral regional oxygen saturation. The benefit of NIRS followups of cerebral and somatic (liver, kidney, mesentery) oxygenation in pediatric cardiovascular surgery patients are demonstrated by studies.

Conditions

Acute Kidney Injury; Children; Cardiac Surgery

Keywords

regional oximetry; cerebral oximetry

Outcome Measures

Primary Outcomes (3)

• Early prediction of postoperative acute renal injury with TEE

  Intraoperative renal blood flow assessment with TEE

  Intraoperative period

• Early prediction of postoperative acute renal injury with transcutaneous renal regional oxygen saturation measured with NIRS

  Renal oxygenation values gained from NIRS monitor during the surgery

  Intraoperative period

• Acute kidney injury

  AKI is staged according to KDIGO

  Postoperative 1 week

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients who meet the inclusion criteria and who will undergo cardiac surgery in our hospital will be included in the study.

You may qualify if:

• pediatric patients
• cardiovascular surgery
• Written informed consent
• Peroperative TEE assessment

You may not qualify if:

• Patients whose follow up cannot be done with TEE (ie Patients whose body weight is less than 5 kg, patients with esophageal pathologies)
• Patients with renal insufficiency
• Patients whose TEE evaluation cannot be done optimally will be left out of the study

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Education and Research Hospital

Istanbul, Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alper Kararmaz, Prof

  Marmara University Pendik Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 1, 2018
• Study Start: May 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: April 30, 2019
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

TU (1)