Clinical trial NCT02144766: Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
Official title: Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Dysfunction
Myocardial Injury
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
timeFrame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
measure: change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery
timeFrame: baseline(before induction of anesthesia), 3h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery
timeFrame: baseline(before induction of anesthesia), 24h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery
timeFrame: baseline(before induction of anesthesia), 48h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery
timeFrame: baseline(before induction of anesthesia), 72h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit
timeFrame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
measure: change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery
timeFrame: baseline(before induction of anesthesia), 3h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery
timeFrame: baseline(before induction of anesthesia), 24h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery
timeFrame: baseline(before induction of anesthesia), 48h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery
timeFrame: baseline(before induction of anesthesia), 72h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit
timeFrame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
measure: change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery
timeFrame: baseline(before induction of anesthesia), 3h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery
timeFrame: baseline(before induction of anesthesia), 24h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery
timeFrame: baseline(before induction of anesthesia), 48h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery
timeFrame: baseline(before induction of anesthesia), 72h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit
timeFrame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
measure: change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery
timeFrame: baseline(before induction of anesthesia), 3h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery
timeFrame: baseline(before induction of anesthesia), 24h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery
timeFrame: baseline(before induction of anesthesia), 48h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery
timeFrame: baseline(before induction of anesthesia), 72h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit
timeFrame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
measure: change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery
timeFrame: baseline(before induction of anesthesia), 3h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery
timeFrame: baseline(before induction of anesthesia), 24h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery
timeFrame: baseline(before induction of anesthesia), 48h after surgery
measure: change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery
timeFrame: baseline(before induction of anesthesia), 72h after surgery
Secondary outcomes:
measure: change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit
timeFrame: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
measure: change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery
timeFrame: baseline(just before the start of surgery), 3h after surgery
measure: change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit
timeFrame: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
measure: change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery
timeFrame: baseline(just before the start of surgery), 3h after surgery
measure: change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit
timeFrame: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
measure: change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery
timeFrame: baseline(just before the start of surgery), 3h after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
References: