Effects of Anesthetic Techniques on Renal Function

October 17, 2019 updated by: Huiying Shao

Different Effects of Two Anesthetic Techniques on Renal Function During the Perioperative Period of Cardiac Surgery in Children

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • preoperative renal insufficiency;
  • renal malformation, kidney absence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
sevoflurane was used to maintain 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
propofol was used to maintain anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal blood flow
Time Frame: 2 days
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)
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neutrophil gelatinase-associated lipocalin , NGAL
Time Frame: 2 days
Changes of blood NGAL were obtained before and 2 hours after surgery, unit(ng/ml)
2 days
creatinine
Time Frame: 3 and 4 days
Changes of creatinine before and 3 days after acquisition, unit (mmol/L)
3 and 4 days
Mean arterial pressure
Time Frame: 2 days
Mean arterial pressure synchronized with renal blood flow was recorded, unit (mmHg)
2 days
cardiopulmonary bypass (CPB) time
Time Frame: 24 hours
Cardiopulmonary bypass time was recorded, unit(minutes)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huiying Shao

Investigators

  • Study Director: mazhong zhang, MD, Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 21, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEOTATORFDTPPOCSIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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