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CompletedNCT04030481Updated Oct 21, 2019

Effects of Anesthetic Techniques on Renal Function

An observational study in Congenital Heart Disease and Acute Kidney Injury, sponsored by Huiying Shao. Completed at 1 site in China. Open to participants aged 1 Minute to 3 Years. Per ClinicalTrials.gov, last updated 2019-10-21.

Sponsored by Huiying Shao · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
1 Minute to 3 Years
Sex
All
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Study summary

This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.

Read the detailed description

Acute kidney injury is one of the major complications after heart surgery, which increases the mortality of patients. Therefore, early prevention and detection of acute kidney injury is particularly important. In recent years, more and more studies have shown that both sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an intravenous anesthetic, have protective effects on kidneys. The aim of this study was to investigate the perioperative effects of two different anesthetic techniques on renal function for pediatric cardiac surgery.

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Conditions studied

  • Congenital Heart Disease
  • Acute Kidney Injury

Keywords

  • propofol,sevoflurane
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 60 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

This is the only study on the registry with Huiying Shao as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

After approved by the ethics committee, sixty patients who met the inclusion criteria of this study with their parents' informed consent in Children's Hospital of Fudan University.

Inclusion criteria

  • children with congenital heart disease
  • \<3 years of age

Exclusion criteria

Exclusion Criteria:

  • preoperative renal insufficiency;
  • renal malformation, kidney absence
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A: Sevoflurane, sufentanil and rocuronium

    sevoflurane (1-3%)and sufentanil (0.5-2 mcg/kg/h) and rocuronium (0.3~0.6mg/kg/h) used intraoperatively as required

    Other: inhalation anesthesia

  • Group B: Propofol, sufentanil and rocuronium

    propofol (4-12 mg/kg/h) and sufentanil (0.5-2 mcg/kg/h/) and rocuronium (0.3~0.6mg/kg/h) used intraoperatively as required

    Other: Total intravenous anesthesia

Interventions

  • Otherinhalation anesthesia

    sevoflurane was used to maintain anesthesia

  • OtherTotal intravenous anesthesia

    propofol was used to maintain anesthesia

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What researchers measure

Primary outcomes

  1. renal blood flow

    Changes of blood flow information of renal artery was obtained before anesthesia induction, after anesthesia, at the end of operation and 24 hours after surgery, unit(cm/s)

    Time frame: 2 days

Secondary outcomes

  1. neutrophil gelatinase-associated lipocalin , NGAL

    Changes of blood NGAL were obtained before and 2 hours after surgery, unit(ng/ml)

    Time frame: 2 days

  2. creatinine

    Changes of creatinine before and 3 days after acquisition, unit (mmol/L)

    Time frame: 3 and 4 days

  3. Mean arterial pressure

    Mean arterial pressure synchronized with renal blood flow was recorded, unit (mmHg)

    Time frame: 2 days

  4. cardiopulmonary bypass (CPB) time

    Cardiopulmonary bypass time was recorded, unit(minutes)

    Time frame: 24 hours

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Study locations

1 site
  • Children's Hospital of Fudan University
    Shanghai, Shanghai, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04030481
Lead sponsor
Huiying Shao
Responsible party
Huiying Shao (The attending anesthesiologist, Children's Hospital of Fudan University) — Sponsor-investigator
First posted
Jul 24, 2019
Start date
Jan 1, 2019
Primary completion
Sep 30, 2019
Completion
Sep 30, 2019
Last update
Oct 21, 2019

Study contacts

mazhong zhang, MD
study director · Shanghai Children's Medical Center

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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