Cardiac DysfunctionPhase 4NCT02144766
Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
A Phase 4 study testing ropivacaine and saline in people with Cardiac Dysfunction and Myocardial Injury, run by Si-Qin Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Cardiac Dysfunction, Myocardial Injury
- What is being tested?
- ropivacaine and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
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.
- Conditions
- Cardiac Dysfunction, Myocardial Injury
- Being tested
- ropivacaine, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
caudal block with 1 ml/kg of ropivacaine 0.2%
salineDrug
caudal block with 1 ml/kg of saline
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | caudal block with 1 ml/kg of ropivacaine 0.2% Receives: Drug: ropivacaine |
| saline | Placebo comparator | caudal block with 1 ml/kg of saline Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery
Measured: baseline(just before the start of surgery), 3h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Si-Qin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Si-Qin Chen, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144766
- Sponsor's protocol ID
- 060717
- Status last verified
- Aug 2014
- First submitted
- 11 May 2014
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
- ClinicalTrials.gov ID
- NCT02144766
- Acronym / sponsor ID
- 060717
- Conditions
- Cardiac Dysfunction, Myocardial Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Si-Qin ChenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: ropivacainecaudal block with 1 ml/kg of ropivacaine 0.2% |
| saline | Placebo comparator | Drug: salinecaudal block with 1 ml/kg of saline |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacainecaudal block with 1 ml/kg of ropivacaine 0.2% | Drug | Ropivacaine |
| salinecaudal block with 1 ml/kg of saline | Drug | saline |
Primary outcome
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline(before induction of anesthesia), 72h after surgery
6 secondary outcomes
change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery
Time frame: baseline(just before the start of surgery), 3h after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine and saline in people with Cardiac Dysfunction and Myocardial Injury, run by Si-Qin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SiQin Chen, MD (+8613918085974, chensiqin1983@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit (time frame: baseline(before induction of anesthesia), arrival in the postanesthesia care unit). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.