NCT04030481

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

July 2, 2019

Last Update Submit

October 17, 2019

Conditions

Keywords

propofol,sevoflurane

Outcome Measures

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)

    2 days

Secondary Outcomes (4)

  • neutrophil gelatinase-associated lipocalin , NGAL

    2 days

  • creatinine

    3 and 4 days

  • Mean arterial pressure

    2 days

  • cardiopulmonary bypass (CPB) time

    24 hours

Study Arms (2)

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

sevoflurane was used to maintain anesthesia

Group A: Sevoflurane, sufentanil and rocuronium

propofol was used to maintain anesthesia

Group B: Propofol, sufentanil and rocuronium

Eligibility Criteria

Age1 Minute - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • preoperative renal insufficiency;
  • renal malformation, kidney absence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Heart Defects, CongenitalAcute Kidney Injury

Interventions

Anesthesia, Inhalation

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, GeneralAnesthesiaAnesthesia and Analgesia

Study Officials

  • mazhong zhang, MD

    Shanghai Children's Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The attending anesthesiologist

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 24, 2019

Study Start

January 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations