Perioperative/Postoperative ComplicationsNCT01340742
Remote Ischemic Preconditioning Before Abdominal Surgery
A study testing Remote Ischemic Pre-conditioning in people with Perioperative/Postoperative Complications, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%. Ischemic preconditioning may have a protective effect. The purpose of this study is to find out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a protective effect. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Remote Ischemic Pre-conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing abdominal surgery:large bowel, pancreatic and hepatic surgery
Who cannot join
- Chronic inflammatory disease.
- Glyburide use before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning Before Abdominal Surgery and the Prevalence of Perioperative Complications
Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.
Ischemic preconditioning may have a protective effect. The purpose of this study is to find out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a protective effect.
- Being tested
- Remote Ischemic Pre-conditioning, Control
- Keywords
- Remote ischemic preconditioning, Abdominal surgery, Perioperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Pre-conditioningProcedure or surgery
Cuff placed on arm. Three 5- minute cycles of blood pressure cuff inflation: cuff is inflated to 200 mm Hg for 5 minutes followed by a 5-minute deflation (reperfusion.)
ControlProcedure or surgery
Cuff placed on arm uninflated for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arm remote preconditioning Receives: Procedure: Remote Ischemic Pre-conditioning |
| 2 | Placebo comparator | Control group. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups
Measured: One week
Secondary outcomes (1)
Renal function deterioration in the first week after surgery
Baseline Creatinine levels will be compared to the highest creatinine levels noted in the first 7 days of hospitalization
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative/Postoperative ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronit Lavi, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340742
- Sponsor's protocol ID
- R-10-132
- Other IDs
- 16811
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2011
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning Before Abdominal Surgery and the Prevalence of Perioperative Complications
- ClinicalTrials.gov ID
- NCT01340742
- Acronym / sponsor ID
- R-10-132
- Keywords
- Remote ischemic preconditioning, Abdominal surgery, Perioperative complications
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 25 Apr 2011 (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.
Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.
Ischemic preconditioning may have a protective effect. The purpose of this study is to find out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a protective effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Remote Ischemic Pre-conditioningArm remote preconditioning |
| 2 | Placebo comparator | Procedure: ControlControl group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing abdominal surgery:large bowel, pancreatic and hepatic surgery
Key exclusion criteria (2 listed)
- Chronic inflammatory disease.
- Glyburide use before surgery.
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 |
|---|---|---|
| Remote Ischemic Pre-conditioningCuff placed on arm. Three 5- minute cycles of blood pressure cuff inflation: cuff is inflated to 200 mm Hg for 5 minutes followed by a 5-minute deflation (reperfusion.) | Procedure or surgery | 1 |
| ControlCuff placed on arm uninflated for 30 minutes. | Procedure or surgery | 2 |
Primary outcome
Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups
Time frame: One week
1 secondary outcome
Renal function deterioration in the first week after surgery
Time frame: One week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
Ronit Lavi, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Pre-conditioning in people with Perioperative/Postoperative Complications, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 2 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: withdrawn, as of the sponsor's last update on 6 Oct 2023. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups (time frame: One week). 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 6 Oct 2023.