Cardiac Surgery PatientsNCT01231789
The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter
A study testing RIPC in people with Cardiac Surgery Patients, run by Xijing Hospital at 1 site in China.
Trial summary
The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Surgery Patients
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Aug 2013
- 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
- Patients diagnosed with acquired heart valve diseases scheduled for valve replacement or CABG
Who cannot join
- Were unable to give informed consent
- Patients who presented with other systemic diseases such as hepatic,renal, and pulmonary diseases, or have had a heart operation before, were excluded.
- Additionally, patients taking antidiabetic sulfonylurea or glibenclamide were excluded because these agents have been shown to abrogate the cardioprotection elicited by ischemic preconditioning.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Hailong Dong, MD,PhD
Hailong Dong, MD,PhD
About this study
Official title: The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter
The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery.
Read the detailed description
BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after cardiac surgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective cardiac surgery, a randomized trial will be performed in current study.
DESIGNING 150 patients will be randomize assigned to cardiac surgery with RIPC or without RIPC (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points.
EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury in cardiac surgery.
CONCLUSIONS:
In patients undergoing elective cardiac surgery, RIPC reduces the incidence of postoperative cerebral injury.
- Conditions
- Cardiac Surgery Patients
- Being tested
- RIPC, sham RIPC
- Keywords
- cardiac surgery, RIPC, brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
Also called remote ischemic preconditioning
RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated
sham RIPCProcedure or surgery
Also called sham remote ischemic preconditioning
Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.
| Study group | Role | What they receive |
|---|---|---|
| sham RIPC | Sham comparator | Patients had a deflated cuff placed on the right upper arm for 30 min. Receives: Procedure: sham RIPC |
| RIPC treatment | Experimental | RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated Receives: Procedure: RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neurological injury markers, including serum level of S-100B and NSE
the biomarkers of brain injury
Measured: before surgery, 6h, 24h, 48h, and 72h after bypass
Secondary outcomes (1)
mini-mental state examination scale
the neurological function
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Dong, MD,PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231789
- Sponsor's protocol ID
- RIPC-Cardiac-Neuroprotection
- Status last verified
- Jun 2009
- First submitted
- 15 Sep 2010
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu S, Zheng Z, Lv W, Ouyang P, Han J, Zhang J, Dong H, Lei C. Neuroprotective effect of remote ischemic preconditioning in patients undergoing cardiac surgery: A randomized controlled trial. Front Cardiovasc Med. 2022 Sep 6;9:952033. doi: 10.3389/fcvm.2022.952033. eCollection 2022.
PubMed 36148077
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter
- ClinicalTrials.gov ID
- NCT01231789
- Acronym / sponsor ID
- RIPC-Cardiac-Neuroprotection
- Conditions
- Cardiac Surgery Patients
- Keywords
- cardiac surgery, RIPC, brain injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 1 Nov 2010 (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 current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery.
Detailed description
BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after cardiac surgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective cardiac surgery, a randomized trial will be performed in current study.
DESIGNING 150 patients will be randomize assigned to cardiac surgery with RIPC or without RIPC (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points.
EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury in cardiac surgery.
CONCLUSIONS:
In patients undergoing elective cardiac surgery, RIPC reduces the incidence of postoperative cerebral injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham RIPC | Sham comparator | Procedure: sham RIPCPatients had a deflated cuff placed on the right upper arm for 30 min. |
| RIPC treatment | Experimental | Procedure: RIPCRIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with acquired heart valve diseases scheduled for valve replacement or CABG
Key exclusion criteria (3 listed)
- Were unable to give informed consent
- Patients who presented with other systemic diseases such as hepatic,renal, and pulmonary diseases, or have had a heart operation before, were excluded.
- Additionally, patients taking antidiabetic sulfonylurea or glibenclamide were excluded because these agents have been shown to abrogate the cardioprotection elicited by ischemic preconditioning.
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 |
|---|---|---|
| RIPCAlso: remote ischemic preconditioningRIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated | Procedure or surgery | RIPC treatment |
| sham RIPCAlso: sham remote ischemic preconditioningPatients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure. | Procedure or surgery | sham RIPC |
Primary outcome
the neurological injury markers, including serum level of S-100B and NSE
Time frame: before surgery, 6h, 24h, 48h, and 72h after bypass
the biomarkers of brain injury
1 secondary outcome
mini-mental state examination scale
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Derived from this study: PubMed 36148077Zhu S, Zheng Z, Lv W, Ouyang P, Han J, Zhang J, Dong H, Lei C. Neuroprotective effect of remote ischemic preconditioning in patients undergoing cardiac surgery: A randomized controlled trial. Front Cardiovasc Med. 2022 Sep 6;9:952033. doi: 10.3389/fcvm.2022.952033. eCollection 2022.
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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.
Hailong Dong, MD,PhD principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with Cardiac Surgery Patients, run by Xijing Hospital 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 3 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 21 Aug 2012. 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.
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 Hailong DONG, MD, PhD (86-2984775337, hldong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neurological injury markers, including serum level of S-100B and NSE (time frame: before surgery, 6h, 24h, 48h, and 72h after bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231789, which also lists 1 linked publication.
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 21 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.