Elderly PatientsLRIP-DNCT03028389
Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery
A study testing limb remote ischemic preconditioning(LRIP) in people with Elderly Patients and Non-cardiac Surgery, run by Nanfang Hospital, Southern Medical University.
Trial summary
To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patients, Non-cardiac Surgery
- What is being tested?
- limb remote ischemic preconditioning(LRIP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2017to Feb 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elderly patients received elective non-cardiac surgery with general anesthesia
- anticipated surgery time > 2 hours
Who cannot join
- age < 65 years old
- Acute coronary syndrome or myocardial infraction within 3 months
- Chronic obstructive pulmonary emphysema
- Serious hepatic dysfunction (Child-Pugh class C)
- serious renal dysfunction (undergoing dialysis before surgery)
- Ejection fraction less than 40%
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- Poor pulmonary function (PaO2 <60mmHg)
- Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
- Inability to communicate in the preoperative period (coma, profound dementia, or language barrier)
- Brain injury or neurosurgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery:a Randomised, Double-blind, Placebo-controlled Trial
To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.
Read the detailed description
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes included the incidence of delirium in the first 7 days after surgery using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a 6-month period was evaluated as well.Secondary endpoints included length of stay in the hospital after surgery (from day of surgery to hospital discharge), occurrence of non-delirium postoperative complications, and all-cause 6-month mortality.
- Conditions
- Elderly Patients, Non-cardiac Surgery
- Being tested
- limb remote ischemic preconditioning(LRIP)
- Keywords
- elderly patients, non-cardiac surgery, ischemic preconditioning, delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limb remote ischemic preconditioning(LRIP)Procedure or surgery
Also called LRIP
LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
| Study group | Role | What they receive |
|---|---|---|
| Limb RIPC | Experimental | The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff. Receives: Procedure: limb remote ischemic preconditioning(LRIP) |
| Convention | No intervention | Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of delirium
Measured: in the first 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Feb 2017 (estimated)
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 611 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kexuan Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Ke-Xuan Liu, Ph.D, Principal investigator, Nanfang Hospital, the Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028389
- Sponsor's protocol ID
- LRIP20170116
- Acronym
- LRIP-D
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 23 Jan 2017
- 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 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery:a Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03028389
- Acronym / sponsor ID
- LRIP-D / LRIP20170116
- Conditions
- Elderly Patients, Non-cardiac Surgery
- Keywords
- elderly patients, non-cardiac surgery, ischemic preconditioning, delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 611 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (estimated)
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 23 Jan 2017 (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.
To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.
Detailed description
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes included the incidence of delirium in the first 7 days after surgery using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a 6-month period was evaluated as well.Secondary endpoints included length of stay in the hospital after surgery (from day of surgery to hospital discharge), occurrence of non-delirium postoperative complications, and all-cause 6-month mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limb RIPC | Experimental | Procedure: limb remote ischemic preconditioning(LRIP)The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff. |
| Convention | No intervention | –Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- elderly patients received elective non-cardiac surgery with general anesthesia
- anticipated surgery time > 2 hours
Key exclusion criteria (10 listed)
- age < 65 years old
- Acute coronary syndrome or myocardial infraction within 3 months
- Chronic obstructive pulmonary emphysema
- Serious hepatic dysfunction (Child-Pugh class C)
- serious renal dysfunction (undergoing dialysis 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 |
|---|---|---|
| limb remote ischemic preconditioning(LRIP)Also: LRIPLRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated. | Procedure or surgery | Limb RIPC |
Primary outcome
the incidence of delirium
Time frame: in the first 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- 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.
Ke-Xuan Liu, Ph.D principal investigator
Nanfang Hospital, the Southern Medical University
Questions about this trial
What is this clinical trial studying?
A study testing limb remote ischemic preconditioning(LRIP) in people with Elderly Patients and Non-cardiac Surgery, run by Nanfang Hospital, Southern Medical University.
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 2 inclusion and 10 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Jian Liu, MD (+86-15013228487, launfyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of delirium (time frame: in the first 7 days after surgery). 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 23 Jan 2017.