Tissue Oxygenation During Treatment of Infant Congenital Heart Defects

NCT03941015 | Completed Results

• 1 other identifier: 2018009
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Acute kidney injury (AKI) is a common and serious postoperative complication in children with congenital heart disease. In this prospective cohort study, we tested the hypothesis that renal desaturation defined as a 20% decline of renal tissue oxygen saturation (SrtO2) from the baseline value is associated with AKI in infants undergoing ventricular septal defect (VSD) repair with cardiopulmonary bypass (CPB). Methods: Infants aged 1 months to 12 months and scheduled to undergo VSD repair with CPB were eligible. SrtO2 was monitored using a tissue near-infrared spectroscopy. Renal desaturation was defined as a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. The primary outcome was the incidence of AKI on postoperative 1-3 days according to the Kidney Disease: Improving Global Outcomes criteria. The secondary outcomes included different stages of AKI, duration of postoperative mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, renal replacement therapy (RRT), and in-hospital mortality.

Conditions

Acute Kidney Injury; Hypoxia-Ischemia, Brain; Mesenteric Ischemia

Keywords

Near infrared spectroscopy; Acute Kidney Injury; congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Kidney Injury

  AKI was diagnosed per the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Acute kidney injury was defined as an increase in serum creatinine to ≥1.5 times baseline within 3 days after surgery. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured within one week before surgery was defined as serum creatinine baseline.

  3 days

Secondary Outcomes (6)

• Duration of Mechanical Ventilation

  up to 1440 hours

• Length of Hospital Stay

  up to 60 days

• Duration of Stay in the Intensive Care Unit

  up to 60 days

• Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 1

  3 days

• Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 2

  3 days

Study Arms (2)

patients with renal desaturation

Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.

patients without renal desaturation

Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants aged 1 month to 12 months and scheduled to undergo ventricular septal defect repair with cardiopulmenary bypass were eligible.

You may qualify if:

• Age ≤ 1 year
• Diagnosis of ventricular septal defect
• Undergoing cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• refusal to participate;
• emergent or urgent surgery;
• weight \>10 kg;
• preoperative renal dysfunction;
• multiple organ dysfunction;
• chromosomal abnormalities;
• skin condition precluding the application of near-infrared spectroscopy probe.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Anzhen hospital, Beijing

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

• Zhang D, Ouyang C, Zhao X, Cui B, Dai F, Meng L, Ma J. Renal tissue desaturation and acute kidney injury in infant cardiac surgery: a prospective propensity score-matched cohort study. Br J Anaesth. 2021 Oct;127(4):620-628. doi: 10.1016/j.bja.2021.06.045. Epub 2021 Aug 24.

  PMID: 34446224 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

* urine samples * blood samples * stool samples

MeSH Terms

Conditions

Acute Kidney Injury; Hypoxia-Ischemia, Brain; Mesenteric Ischemia; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Peritoneal Diseases; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Jun Ma
• Organization: Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University

18710168703@163.com

13370103671

Study Officials

• Boqun Cui, MA

  Anzhen hospital Beijing China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the chief of department of anesthesiology

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: May 7, 2019
• Study Start: December 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: January 30, 2021
• Last Updated: March 17, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-02

Locations

CN (1)