Acute Kidney InjuryNCT03941015
Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
An observational study of Acute Kidney Injury and Hypoxia-Ischemia, Brain, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Acute Kidney Injury, Hypoxia-Ischemia, Brain, Mesenteric Ischemia
- How many people
- 245 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Jan 2021
- Phase
- Observational
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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants aged 1 month to 12 months and scheduled to undergo ventricular septal defect repair with cardiopulmenary bypass were eligible.
Who may be able to join
- Age ≤ 1 year
- Diagnosis of ventricular septal defect
- Undergoing cardiac surgery with cardiopulmonary bypass
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Using near-infrared spectroscopy (NIRS) to monitor intraoperative and postoperative tissue oxygen saturation and to investigate the correlation with postoperative complications.
Intraoperative hemodynamic parameters were monitored by Mostcare(PRAM, Vygon Health, Padua, Italy) including cardiac index, systemic vascular resistance index, stroke volume index, the maximal slope of systolic upstroke, cardiac cycle efficiency.
SrtO2 was monitored using a tissue near-infrared spectroscopy (FORE-SIGHT ELITE tissue oximeter, CASMED, Branford, Connecticut, USA; now acquired by Edwards Lifesciences, Irvine, California, USA). A biophotonic sensor was placed on the left flank at the level of T10-L2 to monitor SrtO2. The tissue oximeter generated a new SrtO2 data every 2 seconds. All these data were exported from the monitor as the end of surgery. As this is an observational study, the SrtO2 data were only used for research purpose, not for clinical decision making. The function of tissue oximeter was checked by a dedicated research personnel in the operating room. The infant was dropped from the study if the SrtO2 measurements were not available for more than 5 min during surgery. The baseline SrtO2 was defined as the median value of the 5-minute measurements which were measured following anesthesia induction and during the period when the cardiac index ≥2.5 L/min/m2. 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 electronic data streams from the NIRS and other patient monitors will be collected into a study computer. Data collection will initiate at pre-induction of anesthesia in the operating room. Only the NIRS values will be blinded from clinical use. Blood samples for determining biomarkers of ischemic tissue injury will be taken at defined intervals. No other modifications to clinical practice will occur while conducting the study and the NIRS monitoring is non-invasive.
The primary outcome was the incidence of AKI within 3 days after surgery according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary outcomes including different stages of AKI, duration of postoperative mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, and in-hospital mortality.
- Keywords
- Near infrared spectroscopy, Acute Kidney Injury, congenital heart disease
- Medical subject headings
- Acute Kidney Injury, Hypoxia-Ischemia, Brain, Mesenteric Ischemia, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (6)
Duration of Mechanical Ventilation
Hours of mechanical ventilation after surgery
Measured: up to 1440 hours
Length of Hospital Stay
Length of hospital stay after surgery
Measured: up to 60 days
Duration of Stay in the Intensive Care Unit
Duration of Stay in the intensive care unit after surgery
Measured: up to 60 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 1
KDIGO stage 1 was defined as serum creatinine increased more than 1.5 times serum creatinine baseline. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. KDIGO stage 1 was considered as mild acute kidney injury.
Measured: 3 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 2
KDIGO stage 2 was defined as serum creatinine increased more than 2 times serum creatinine baseline and less than 3 times serum creatinine baseline. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. Acute kidney injury in KDIGO stage 2 was more serious than acute kidney injury in stage 1.
Measured: 3 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3
KDIGO stage 3 was defined as serum creatinine increased more than 3 times baseline, or dialysis requirement, or estimated GFR less than 35 mL/min/1.73m2. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. Acute kidney injury in KDIGO stage 3 was more serious than acute kidney injury in stage 2.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Dec 2018
- Primary completion31 Aug 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, Beijing Anzhen Hospital
- Investigators
- Boqun Cui, MA, Principal investigator, Anzhen hospital Beijing China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941015
- Sponsor's protocol ID
- 2018009
- Status last verified
- Feb 2021
- First submitted
- 19 Nov 2018
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34446224