Intestinal ComplicationsCIPSNCT03216759
Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications
A study testing Ischemic preconditioning and Dexmedetomidine in people with Intestinal Complications and Laparotomy, run by Nanfang Hospital, Southern Medical University.
Trial summary
To investigate the morbidity of intestinal injury after open surgery and observe the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intestinal Complications, Laparotomy
- What is being tested?
- Ischemic preconditioning and Dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to 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
- Aged between 18 and 70 years;
- Elective abdominal surgery under general anesthesia, operation time > 2h;
- ASA Ⅰ ~ Ⅲ;
- Patient informed and consent to accept the test.
Who cannot join
- persons under the age of 18 or over 70 years old;
- pregnant or lactating women;
- combined with lung, liver, kidney, cardiovascular and hematopoietic system disease and other serious primary disease;
- preoperative Hb <7g / l;
- oral sulfa drugs or nicorandil antihypertensive drugs;
- lower extremity amputees;
Show all 11Show fewer
- with peripheral vascular disease;
- patients with mental illness or severe neurosis;
- can not express the subjective symptoms;
- nearly 3 months to participate in other drug clinical trials;
- within 3 months of receiving other surgical treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications in Patients Undergoing Laparotomy With General Anesthesia
To investigate the morbidity of intestinal injury after open surgery and observe the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia.
Read the detailed description
Perioperative intestinal injury is one of the common tissues and organs injury in surgical practice. However, there is a lack of effective means of prevention and treatment.The investigators previously found that ischemic preconditioning, IPC, and dexmedetomidine has protective effects on intestinal mucosal injury.
However, the combined effect of various factors has not been clinically validated. To explore the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia,the investigators select the patients undergoing open surgery under general anesthesia as the study subjects and the concentration of intestinal fatty acid binding protein (I-FABP) as well as the incidence of digestive system complications in one week after operation are the main observation indexes.
- Conditions
- Intestinal Complications, Laparotomy
- Being tested
- Ischemic preconditioning, Dexmedetomidine, Patient-controlled epidural analgesia
- Keywords
- Comprehensive intestinal protection strategy, Intestinal complications, laparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioningProcedure or surgery
After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning.
DexmedetomidineDrug
At the beginning of anesthesia induction, 3 ug/kg/h of dexmedetomidine was infused and adjusted to 0.3 ug/kg/h after 10 min of infusion until 30 minutes before the end of the procedure.
Patient-controlled epidural analgesiaProcedure or surgery
Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.The first volume of morphine 2mg + 0.2% ropivacaine + 0.9% saline 6ml, maintenance dose of morphine 18mg + 0.1% ropivacaine + 0.9% saline total 150ml. PCEA work with a continuous background dose of 2 ml/h with a single dose of 2ml/time, load 2ml, locking time 15min.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Tourniquet would be tied to left upper limb of Patients who undergoing laparotomy for 30 minutes after the induction of anesthesia,but put no press on it. Other processes are consistent with conventional methods. |
| intervention | Experimental | 1. After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning.
2. At the beginning of anesthesia induction, 3 μg / kg / h of dexmedetomidine was infused and adjusted to 0.3 ug / kg / h after 10 min of infusion until 30 minutes before the end of the procedure.
3. Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap. Receives: Procedure: Ischemic preconditioning; Drug: Dexmedetomidine; Procedure: Patient-controlled epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of digestive system complications after operation
The incidence of digestive system complications within one week after surgery
Measured: 12 hours to one week after surgery
The concentration of intestinal fatty acid-binding protein (I-FABP)
The concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation
Measured: 12 h after operation
Secondary outcomes (1)
Postoperative heart and respiratory complications within one week
Postoperative heart and respiratory complications within one week
Measured: 12 hours to one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intestinal ComplicationsStudies 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
- 182 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
- NCT03216759
- Sponsor's protocol ID
- CIPS
- Acronym
- CIPS
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.
PubMed 20484066Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
PubMed 17707752
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications in Patients Undergoing Laparotomy With General Anesthesia
- ClinicalTrials.gov ID
- NCT03216759
- Acronym / sponsor ID
- CIPS / CIPS
- Conditions
- Intestinal Complications, Laparotomy
- Keywords
- Comprehensive intestinal protection strategy, Intestinal complications, laparotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Jul 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 investigate the morbidity of intestinal injury after open surgery and observe the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia.
Detailed description
Perioperative intestinal injury is one of the common tissues and organs injury in surgical practice. However, there is a lack of effective means of prevention and treatment.The investigators previously found that ischemic preconditioning, IPC, and dexmedetomidine has protective effects on intestinal mucosal injury.
However, the combined effect of various factors has not been clinically validated. To explore the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia,the investigators select the patients undergoing open surgery under general anesthesia as the study subjects and the concentration of intestinal fatty acid binding protein (I-FABP) as well as the incidence of digestive system complications in one week after operation are the main observation indexes.
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 |
|---|---|---|
| control group | No intervention | –Tourniquet would be tied to left upper limb of Patients who undergoing laparotomy for 30 minutes after the induction of anesthesia,but put no press on it. Other processes are consistent with conventional methods. |
| intervention | Experimental | Procedure: Ischemic preconditioning, Drug: Dexmedetomidine, Procedure: Patient-controlled epidural analgesia1. After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning. 2. At the beginning of anesthesia induction, 3 μg / kg / h of dexmedetomidine was infused and adjusted to 0.3 ug / kg / h after 10 min of infusion until 30 minutes before the end of the procedure. 3. Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 70 years;
- Elective abdominal surgery under general anesthesia, operation time > 2h;
- ASA Ⅰ ~ Ⅲ;
- Patient informed and consent to accept the test.
Key exclusion criteria (11 listed)
- persons under the age of 18 or over 70 years old;
- pregnant or lactating women;
- combined with lung, liver, kidney, cardiovascular and hematopoietic system disease and other serious primary disease;
- preoperative Hb <7g / l;
- oral sulfa drugs or nicorandil antihypertensive drugs;
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 |
|---|---|---|
| Ischemic preconditioningAfter the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning. | Procedure or surgery | intervention |
| DexmedetomidineAt the beginning of anesthesia induction, 3 ug/kg/h of dexmedetomidine was infused and adjusted to 0.3 ug/kg/h after 10 min of infusion until 30 minutes before the end of the procedure. | Drug | intervention |
| Patient-controlled epidural analgesiaBefore the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.The first volume of morphine 2mg + 0.2% ropivacaine + 0.9% saline 6ml, maintenance dose of morphine 18mg + 0.1% ropivacaine + 0.9% saline total 150ml. PCEA work with a continuous background dose of 2 ml/h with a single dose of 2ml/time, load 2ml, locking time 15min. | Procedure or surgery | intervention |
Primary outcome
The incidence of digestive system complications after operation
Time frame: 12 hours to one week after surgery
The incidence of digestive system complications within one week after surgery
The concentration of intestinal fatty acid-binding protein (I-FABP)
Time frame: 12 h after operation
The concentration of intestinal fatty acid-binding protein (I-FABP) at 12 h after operation
1 secondary outcome
Postoperative heart and respiratory complications within one week
Time frame: 12 hours to one week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Background: PubMed 20484066Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.
- Results publication: PubMed 17707752Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
- 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 Ischemic preconditioning and Dexmedetomidine in people with Intestinal Complications and Laparotomy, 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 4 inclusion and 11 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 13 Jul 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 Cai Li, M.D (+86-18602017796, licaisysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of digestive system complications after operation (time frame: 12 hours to one week after surgery). The study lists 2 primary outcomes in all. 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 NCT03216759, which also lists 2 linked publications.
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 13 Jul 2017.