Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT03723993
Status:
WITHDRAWN
Last Update Posted:
2021-02-03
First Post:
2018-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Ischemic Preconditioning During Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000140', 'term': 'Acidosis, Lactic'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Finished', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-10-26', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': '1 hour before operation once the patient is recruited', 'description': 'in years'}], 'primaryOutcomes': [{'measure': 'Serum lactate level', 'timeFrame': '1 minute at the end of operation', 'description': 'mmol/l from arterial blood gas sample'}], 'secondaryOutcomes': [{'measure': 'Serum lactate level', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'mmol/l from arterial blood gas sample'}, {'measure': 'Serum lactate level', 'timeFrame': '30 minutes, after cardiopulmonary bypass', 'description': 'mmol/l from arterial blood gas sample'}, {'measure': 'Serum lactate level', 'timeFrame': '1 minute before cardiopulmonary bypass', 'description': 'mmol/l from arterial blood gas sample'}, {'measure': 'Serum lactate level', 'timeFrame': '24 hours postoperatively.', 'description': 'mmol/l from arterial blood gas sample'}, {'measure': 'Serum lactate level', 'timeFrame': '48 hours postoperatively.', 'description': 'mmol/l from arterial blood gas sample'}, {'measure': 'Serum lactate level', 'timeFrame': '72 hours postoperatively.', 'description': 'mmol/l from arterial blood gas sample'}, {'measure': 'Heart rate', 'timeFrame': '2 minutes before induction of general anesthesia', 'description': 'beat per minute from electrocardiogram'}, {'measure': 'Heart rate', 'timeFrame': '3 minutes after induction of general anesthesia', 'description': 'beat per minute from electrocardiogram'}, {'measure': 'Heart rate', 'timeFrame': 'Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia', 'description': 'beat per minute from electrocardiogram'}, {'measure': 'Systolic blood pressure', 'timeFrame': '2 minutes before induction of general anesthesia', 'description': 'Measured by mmHg from invasive arterial blood pressure'}, {'measure': 'Systolic blood pressure', 'timeFrame': '3 minutes after induction', 'description': 'Measured by mmHg from invasive arterial blood pressure'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure', 'description': 'Measured by mmHg from invasive arterial blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '2 minutes before induction of general anesthesia', 'description': 'Measured by mmHg from invasive arterial blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '3 minutes after induction', 'description': 'Measured by mmHg from invasive arterial blood pressure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure', 'description': 'Measured by mmHg from invasive arterial blood pressure'}, {'measure': 'Left ventricular fractional shortening (LVFS)', 'timeFrame': '12 hours before the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular fractional shortening (LVFS)', 'timeFrame': '2 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular fractional shortening (LVFS)', 'timeFrame': '4 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular fractional shortening (LVFS)', 'timeFrame': '12 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular fractional shortening (LVFS)', 'timeFrame': '24 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular fractional shortening (LVFS)', 'timeFrame': '48 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular fractional shortening (LVFS)', 'timeFrame': '72 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': '12 hours before the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': '2 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': '4 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': '12 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': '24 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': '48 hours after the operation', 'description': 'measured in percentage derived from echocardiography'}, {'measure': 'Central venous pressure', 'timeFrame': 'Baseline 2 minutes after insertion of central venous catheter', 'description': 'from central venous catheter measured in cm H2O'}, {'measure': 'Central venous pressure', 'timeFrame': '2 minutes before cardiopulmonary bypass', 'description': 'from central venous catheter measured in cm H2O'}, {'measure': 'Central venous pressure', 'timeFrame': '2 minutes after cardiopulmonary bypass', 'description': 'from central venous catheter measured in cm H2O'}, {'measure': 'Central venous pressure', 'timeFrame': '1 minute after the end of operation', 'description': 'from central venous catheter measured in cm H2O'}, {'measure': 'Serum urea level', 'timeFrame': '5 minutes before beginning of operation', 'description': 'mmol/L'}, {'measure': 'Serum urea level', 'timeFrame': '5 minutes after ICU admission', 'description': 'mmol/L'}, {'measure': 'Serum creatinine level', 'timeFrame': '5 minutes before beginning of operation', 'description': 'mmol/L'}, {'measure': 'Serum creatinine level', 'timeFrame': '24 hours postoperatively', 'description': 'mmol/L'}, {'measure': 'Serum creatinine level', 'timeFrame': '48 hours postoperatively', 'description': 'mmol/L'}, {'measure': 'Serum creatinine level', 'timeFrame': '72 hours postoperatively', 'description': 'mmol/L'}, {'measure': 'Acute kidney injury (AKI) score', 'timeFrame': '24 hours postoperatively', 'description': 'Grade 1: serum creatinine rise of 150%-200% of baseline and/or urine output \\<0.5 mL/kg/h for \\>6 contiguous hours.\n\nGrade 2: serum creatinine rise of 200%-300% of baseline and/or urine output \\<0.5 mL/kg/h for \\>12 contiguous hours.\n\nGrade 3: serum creatinine rise of \\>300% of baseline and/or urine output \\<0.3 mL/kg/h for \\>24 h or anuria for 12 h.'}, {'measure': 'Acute kidney injury (AKI) score', 'timeFrame': '48 hours postoperatively', 'description': 'Grade 1: serum creatinine rise of 150%-200% of baseline and/or urine output \\<0.5 mL/kg/h for \\>6 contiguous hours.\n\nGrade 2: serum creatinine rise of 200%-300% of baseline and/or urine output \\<0.5 mL/kg/h for \\>12 contiguous hours.\n\nGrade 3: serum creatinine rise of \\>300% of baseline and/or urine output \\<0.3 mL/kg/h for \\>24 h or anuria for 12 h.'}, {'measure': 'Acute kidney injury (AKI) score', 'timeFrame': '72 hours postoperatively', 'description': 'Grade 1: serum creatinine rise of 150%-200% of baseline and/or urine output \\<0.5 mL/kg/h for \\>6 contiguous hours.\n\nGrade 2: serum creatinine rise of 200%-300% of baseline and/or urine output \\<0.5 mL/kg/h for \\>12 contiguous hours.\n\nGrade 3: serum creatinine rise of \\>300% of baseline and/or urine output \\<0.3 mL/kg/h for \\>24 h or anuria for 12 h.'}, {'measure': 'Serum sodium level', 'timeFrame': '5 minutes after ICU admission.', 'description': 'milliequivalent/L'}, {'measure': 'Serum sodium level', 'timeFrame': '5 minutes before beginning of operation', 'description': 'milliequivalent/L'}, {'measure': 'Serum potassium level', 'timeFrame': '5 minutes before beginning of operation', 'description': 'milliequivalent/L'}, {'measure': 'Serum potassium level', 'timeFrame': '5 minutes after ICU admission', 'description': 'milliequivalent/L'}, {'measure': 'Arterial oxygen pressure', 'timeFrame': '5 minutes before operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial oxygen pressure', 'timeFrame': '2 minutes before cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial oxygen pressure', 'timeFrame': '2 minutes after cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial oxygen pressure', 'timeFrame': '1 minute after end of operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial oxygen pressure', 'timeFrame': 'Every 6 hours for 24 hours in the ICU', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial carbon dioxide pressure', 'timeFrame': '5 minutes before operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial carbon dioxide pressure', 'timeFrame': '2 minutes before cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial carbon dioxide pressure', 'timeFrame': '2 minutes after cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial carbon dioxide pressure', 'timeFrame': '1 minute after end of operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Arterial carbon dioxide pressure', 'timeFrame': 'Every 6 hours for 24 hours in the ICU', 'description': 'From arterial blood gas sampling'}, {'measure': 'Power of hydrogen (pH)', 'timeFrame': '5 minutes before operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Power of hydrogen (pH)', 'timeFrame': '2 minutes before cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Power of hydrogen (pH)', 'timeFrame': '2 minutes after cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Power of hydrogen (pH)', 'timeFrame': '1 minute after end of operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Power of hydrogen (pH)', 'timeFrame': 'Every 6 hours for 24 hours in the ICU', 'description': 'From arterial blood gas sampling'}, {'measure': 'Standard bicarbonate level', 'timeFrame': '5 minutes before operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Standard bicarbonate level', 'timeFrame': '2 minutes before cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Standard bicarbonate level', 'timeFrame': '2 minutes after cardiopulmonary bypass', 'description': 'From arterial blood gas sampling'}, {'measure': 'Standard bicarbonate level', 'timeFrame': '1 minute after end of operation', 'description': 'From arterial blood gas sampling'}, {'measure': 'Standard bicarbonate level', 'timeFrame': 'Every 6 hours for 24 hours in the ICU', 'description': 'From arterial blood gas sampling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic preconditioning', 'Lactate level', 'Cardiopulmonary bypass'], 'conditions': ['Lactic Acidosis']}, 'referencesModule': {'references': [{'pmid': '19549044', 'type': 'BACKGROUND', 'citation': 'Saxena P, Newman MA, Shehatha JS, Redington AN, Konstantinov IE. Remote ischemic conditioning: evolution of the concept, mechanisms, and clinical application. J Card Surg. 2010 Jan-Feb;25(1):127-34. doi: 10.1111/j.1540-8191.2009.00820.x. Epub 2009 Jun 22.'}, {'pmid': '23095318', 'type': 'BACKGROUND', 'citation': 'Heusch G. Cardioprotection: chances and challenges of its translation to the clinic. Lancet. 2013 Jan 12;381(9861):166-75. doi: 10.1016/S0140-6736(12)60916-7. Epub 2012 Oct 22.'}, {'pmid': '23953384', 'type': 'BACKGROUND', 'citation': 'Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhauser M, Peters J, Jakob H, Heusch G. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet. 2013 Aug 17;382(9892):597-604. doi: 10.1016/S0140-6736(13)61450-6.'}, {'pmid': '24338631', 'type': 'BACKGROUND', 'citation': 'Badreldin AM, Doerr F, Elsobky S, Brehm BR, Abul-dahab M, Lehmann T, Bayer O, Wahlers T, Hekmat K. Mortality prediction after cardiac surgery: blood lactate is indispensible. Thorac Cardiovasc Surg. 2013 Dec;61(8):708-17. doi: 10.1055/s-0032-1324796. Epub 2013 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'The objective of study is to detect effect of remote ischemic preconditioning on serum lactate levels during and after cardiac surgery with cardiopulmonary bypass in addition to its effect on cardiac and renal clinical outcomes.', 'detailedDescription': "Remote ischemic preconditioning (RIPC) is a phenomenon where transient non-injurious ischemia/ reperfusion episodes applied to an organ away from the heart can protect the myocardium from ischemia/reperfusion injury. RIPC has been found to be an attractive strategy to reduce myocardial injury and improve outcome in patients undergoing cardiac surgery. The exact mechanisms of this protection are not yet known, although stimulation of prosurvival intracellular kinase responses and inhibition of inflammatory pathways each play a role.\n\nRIPC can be performed by noninvasive inflation and deflation of a standard blood pressure cuff or pneumatic tourniquet on the upper or lower limbs to induce brief ischemia and reperfusion, which is the mechanism by which injury in patients undergoing open cardiac surgery occurs.\n\nANESTHETIC TECHNIQUE All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, renal and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested in patients prepared for coronary artery bypass graft (CABG).\n\nPatient will be premedicated by intramuscular injection of 10mg morphine in the morning of the operation. Before induction of anesthesia, a five-lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. General anesthesia will be induced by fentanyl (3-5 μg/kg), propofol titrated according to response, followed by atracurium (0.5 mg/kg).\n\nTrachea will be intubated, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. This will be confirmed by radial arterial blood gas analysis. An esophageal temperature probe and a Foley catheter will also be placed.\n\nFor drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein.\n\nAnesthesia will be maintained by inhaled isoflurane, with additional fentanyl injected prior to skin incision as well as sternotomy and atracurium infusion for continued muscle relaxation.\n\nDuring extracorporeal circulation, patients will receive propofol infusion in addition to atracurium infusion.\n\nBefore initiation of cardiopulmonary bypass (CPB), the patients will receive intravenously tranexamic acid (2 g) and heparin (300-500 units/kg body weight) to achieve an activated clotting time \\> 400 s. CPB was instituted via an ascending aortic cannula and a two-stage right atrial cannula. Before, during, and after CPB (pump blood flow: 2.4 l/min/m2), mean arterial pressure was adjusted to exceed 60 mmHg. Cardiac arrest will be induced with cold antegrade crystalloid cardioplegia (St Thomas solution) or warm intermittent antegrade blood cardioplegia. Lactate-enriched Ringer's solution will be added to the CPB circuit to maintain reservoir volume when needed, and packed red blood cells will be added when hemoglobin concentration decrease to less than 7 g/dl.\n\nAfter rewarming the patient to 37°C and separation from CPB, reversal of heparin by protamine sulfate, and sternal closure, the patients will be transferred to the intensive care unit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Elective cardiovascular surgery requiring cardiopulmonary bypass either for CABG or valve replacement.\n\nExclusion Criteria:\n\n* Patients with emergency surgeries.\n* Off pump heart surgery.\n* Hepatic affection (INR\\>2).\n* Renal affection (creatinine \\>1.6 mg/dl for men and \\>1.4 mg/dl for women).\n* Peripheral vascular disease affecting upper limbs.\n* Patients taking the antidiabetic sulphonylurea glyburide ( glibenclamide) or receiving nicorandil drug therapy will be excluded because these agents have been shown to abolish preconditioning.\n* Patients being considered for radial artery conduit harvesting.'}, 'identificationModule': {'nctId': 'NCT03723993', 'acronym': 'RIPC', 'briefTitle': 'Remote Ischemic Preconditioning During Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'Effect of Remote Ischemic Preconditioning on Serum Lactate Levels As Well As Cardiac and Renal Functions During and After Open Heart Surgeries', 'orgStudyIdInfo': {'id': 'R123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'control group will have non inflated cuff around the arm.', 'interventionNames': ['Device: Non inflated cuff']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RIPC group', 'description': 'Inflated cuff will be done systematically and regularly', 'interventionNames': ['Device: Inflated cuff']}], 'interventions': [{'name': 'Inflated cuff', 'type': 'DEVICE', 'description': "After patient being draped, applying cuff inflation will be done to the upper arm not having the arterial line inserted of about 200 mmHg or 15 mmHg above patient's systolic pressure 3 cycles 5 minutes each followed by 5 minutes of pressure relieve", 'armGroupLabels': ['RIPC group']}, {'name': 'Non inflated cuff', 'type': 'DEVICE', 'description': 'non inflated cuff around the arm for the control group', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63511', 'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Mohamed Hamed', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'overallOfficials': [{'name': 'Mohamed A Hamed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine, Fayoum University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia', 'investigatorFullName': 'Mohamed Ahmed Hamed', 'investigatorAffiliation': 'Fayoum University'}}}}