Heart Valve DiseasesNCT03186053
Sodium Creatine Phosphate in Heart Valve Surgery
A study testing sodium creatine phosphate and saline in people with Heart Valve Diseases, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites in China.
Trial summary
To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- sodium creatine phosphate and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2017to 31 Dec 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)
Who cannot join
- thoracoscopic valve surgery
- other organ dysfunction: such as cancer, organ failure, severe anemia, infection
- patients with mental disorders
- coagulopathy, active ulcer, ischemic or hemorrhagic stroke (within 6 months), trauma
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Beijing, Beijing Municipality, 100037
Guyan WANG, M.D., +86-13910985139, 13910985139@163.com
Guyan WANG, M.D.
- Recruiting
Cardiovascular Institute and Fuwai Hospital
Beijing, 100037
Guyan Wang, M.D., 86-10-88398082, 13910985139@163.com
About this study
Official title: Cardioprotective Effects of Sodium Creatine Phosphate in Valve Surgery: A Prospective Randomized Controlled Study
To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery
Read the detailed description
Objective: To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Methods: 250 patients undergoing valve surgery were randomly divided into experimental group and control group. 5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). The control group was treated with saline in the same manner. The cTnI level was measured at the corresponding time points. Hemodynamic indexes and postoperative complications were recorded.
- Conditions
- Heart Valve Diseases
- Being tested
- sodium creatine phosphate, saline
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium creatine phosphateDrug
Also called Neoton
sodium creatine phosphate .Loading dose followed by continuous infusion in operation
salineDrug
.Loading dose followed by continuous infusion in operation
| Study group | Role | What they receive |
|---|---|---|
| sodium creatine phosphate | Experimental | 5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). Receives: Drug: sodium creatine phosphate |
| Control | Placebo comparator | The control group was treated with saline in the same manner. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cardiac troponin I(cTnI)
serum cardiac troponin I(cTnI)
Measured: within 24 hours after aortic declamping
Secondary outcomes (6)
mortality
death rate in hospital
Measured: within 30 postoperative days
stroke
defintion by surgeon
Measured: within 30 postoperative days
blood filtration of kidney failure
need for dialysis
Measured: within 30 postoperative days
extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support
heart failure requires mechanical assistance
Measured: within 30 postoperative days
mechanical ventilation time
ventilation
Measured: within 30 postoperative days
arrhythmia
Atrial fibrillation or Ventricular fibrillation or Ventricular tachycardia requiring drug treatments
Measured: within 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Guyan WANG, M.D., Study director, Department of anesthesiology,Fuwai hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186053
- Sponsor's protocol ID
- FWT2017-ZX004
- Status last verified
- Jan 2018
- First submitted
- 29 May 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effects of Sodium Creatine Phosphate in Valve Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03186053
- Acronym / sponsor ID
- FWT2017-ZX004
- Conditions
- Heart Valve Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 14 Jun 2017 (actual)
- 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.
To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery
Detailed description
Objective: To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Methods: 250 patients undergoing valve surgery were randomly divided into experimental group and control group. 5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). The control group was treated with saline in the same manner. The cTnI level was measured at the corresponding time points. Hemodynamic indexes and postoperative complications were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium creatine phosphate | Experimental | Drug: sodium creatine phosphate5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). |
| Control | Placebo comparator | Drug: salineThe control group was treated with saline in the same manner. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)
Key exclusion criteria (4 listed)
- thoracoscopic valve surgery
- other organ dysfunction: such as cancer, organ failure, severe anemia, infection
- patients with mental disorders
- coagulopathy, active ulcer, ischemic or hemorrhagic stroke (within 6 months), trauma
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 |
|---|---|---|
| sodium creatine phosphateAlso: Neotonsodium creatine phosphate .Loading dose followed by continuous infusion in operation | Drug | sodium creatine phosphate |
| saline.Loading dose followed by continuous infusion in operation | Drug | Control |
Primary outcome
serum cardiac troponin I(cTnI)
Time frame: within 24 hours after aortic declamping
serum cardiac troponin I(cTnI)
6 secondary outcomes
mortality
Time frame: within 30 postoperative days
stroke
Time frame: within 30 postoperative days
blood filtration of kidney failure
Time frame: within 30 postoperative days
extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support
Time frame: within 30 postoperative days
mechanical ventilation time
Time frame: within 30 postoperative days
arrhythmia
Time frame: within 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Guyan WANG, M.D. study director
Department of anesthesiology,Fuwai hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium creatine phosphate and saline in people with Heart Valve Diseases, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites 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 4 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Guyan WANG, M.D. (+86-13910985139, 13910985139@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum cardiac troponin I(cTnI) (time frame: within 24 hours after aortic declamping). 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 31 Jan 2018.