NCT02144766

Brief Summary

The goal of the present study was to investigate the role of pro-inflammatory cytokines in myocardial dysfunction and injury resulting from noncardiac injury in children and whether or not anti-inflammatory treatment with caudal block prevents pro-inflammatory cytokines-associated myocardial dysfunction and injury following noncardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

May 11, 2014

Last Update Submit

August 24, 2014

Conditions

Cardiac DysfunctionMyocardial Injury

Outcome Measures

Primary Outcomes (25)

  • change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit

    baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  • change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery

    baseline(before induction of anesthesia), 3h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery

    baseline(before induction of anesthesia), 24h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery

    baseline(before induction of anesthesia), 48h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery

    baseline(before induction of anesthesia), 72h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit

    baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  • change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery

    baseline(before induction of anesthesia), 3h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery

    baseline(before induction of anesthesia), 24h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery

    baseline(before induction of anesthesia), 48h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery

    baseline(before induction of anesthesia), 72h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit

    baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  • change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery

    baseline(before induction of anesthesia), 3h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery

    baseline(before induction of anesthesia), 24h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery

    baseline(before induction of anesthesia), 48h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery

    baseline(before induction of anesthesia), 72h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit

    baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  • change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery

    baseline(before induction of anesthesia), 3h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery

    baseline(before induction of anesthesia), 24h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery

    baseline(before induction of anesthesia), 48h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery

    baseline(before induction of anesthesia), 72h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit

    baseline(before induction of anesthesia), arrival in the postanesthesia care unit

  • change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery

    baseline(before induction of anesthesia), 3h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery

    baseline(before induction of anesthesia), 24h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery

    baseline(before induction of anesthesia), 48h after surgery

  • change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery

    baseline(before induction of anesthesia), 72h after surgery

Secondary Outcomes (6)

  • change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit

    baseline(just before the start of surgery), at arrival in the postanesthesia care unit

  • change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery

    baseline(just before the start of surgery), 3h after surgery

  • change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit

    baseline(just before the start of surgery), at arrival in the postanesthesia care unit

  • change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery

    baseline(just before the start of surgery), 3h after surgery

  • change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit

    baseline(just before the start of surgery), at arrival in the postanesthesia care unit

  • +1 more secondary outcomes

Study Arms (2)

Ropivacaine

EXPERIMENTAL

caudal block with 1 ml/kg of ropivacaine 0.2%

Drug: ropivacaine

saline

PLACEBO COMPARATOR

caudal block with 1 ml/kg of saline

Drug: saline

Interventions

ropivacaineDRUG

caudal block with 1 ml/kg of ropivacaine 0.2%

Ropivacaine
salineDRUG

caudal block with 1 ml/kg of saline

saline

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.

You may not qualify if:

  • Children with anemia, electrolyte disturbances, abnormal acid-base status, bleeding diathesis, history of allergy to local anesthetics, neurologic and spinal diseases, skin infections on the caudal area, renal dysfunction, symptomatic cardiovascular and respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, 200092, China

RECRUITING

MeSH Terms

Interventions

RopivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

SiQin Chen, MD

CONTACT

+8613918085974chensiqin1983@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

May 11, 2014

First Posted

May 22, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations

CN(1)