Lactic Acidosis Clinical Trial
— RIPCOfficial title:
Effect of Remote Ischemic Preconditioning on Serum Lactate Levels As Well As Cardiac and Renal Functions During and After Open Heart Surgeries
NCT number | NCT03723993 |
Other study ID # | R123 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 15, 2018 |
Est. completion date | December 15, 2018 |
Verified date | February 2021 |
Source | Fayoum University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 15, 2018 |
Est. primary completion date | November 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients 18 years of age or older - Elective cardiovascular surgery requiring cardiopulmonary bypass either for CABG or valve replacement. Exclusion Criteria: - Patients with emergency surgeries. - Off pump heart surgery. - Hepatic affection (INR>2). - Renal affection (creatinine >1.6 mg/dl for men and >1.4 mg/dl for women). - Peripheral vascular disease affecting upper limbs. - Patients taking the antidiabetic sulphonylurea glyburide ( glibenclamide) or receiving nicorandil drug therapy will be excluded because these agents have been shown to abolish preconditioning. - Patients being considered for radial artery conduit harvesting. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mohamed Hamed | Fayoum |
Lead Sponsor | Collaborator |
---|---|
Fayoum University |
Egypt,
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. Erratum in: Thorac Cardiovasc Surg. 2013 Jun;61(4):375. Elsobky, Sherif [removed]. Thorac Cardiovasc Surg. 2014 Apr; 62(3):273. Elsobky, Sherif [added]. — View 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. Review. — View 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. Review. — View Citation
Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhäuser 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. Erratum in: Lancet. 2013 Sep 14;382(9896):940. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | in years | 1 hour before operation once the patient is recruited | |
Primary | Serum lactate level | mmol/l from arterial blood gas sample | 1 minute at the end of operation | |
Secondary | Serum lactate level | mmol/l from arterial blood gas sample | 3 minutes after induction of anesthesia | |
Secondary | Serum lactate level | mmol/l from arterial blood gas sample | 30 minutes, after cardiopulmonary bypass | |
Secondary | Serum lactate level | mmol/l from arterial blood gas sample | 1 minute before cardiopulmonary bypass | |
Secondary | Serum lactate level | mmol/l from arterial blood gas sample | 24 hours postoperatively. | |
Secondary | Serum lactate level | mmol/l from arterial blood gas sample | 48 hours postoperatively. | |
Secondary | Serum lactate level | mmol/l from arterial blood gas sample | 72 hours postoperatively. | |
Secondary | Heart rate | beat per minute from electrocardiogram | 2 minutes before induction of general anesthesia | |
Secondary | Heart rate | beat per minute from electrocardiogram | 3 minutes after induction of general anesthesia | |
Secondary | Heart rate | beat per minute from electrocardiogram | Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia | |
Secondary | Systolic blood pressure | Measured by mmHg from invasive arterial blood pressure | 2 minutes before induction of general anesthesia | |
Secondary | Systolic blood pressure | Measured by mmHg from invasive arterial blood pressure | 3 minutes after induction | |
Secondary | Systolic blood pressure | Measured by mmHg from invasive arterial blood pressure | Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure | |
Secondary | Diastolic blood pressure | Measured by mmHg from invasive arterial blood pressure | 2 minutes before induction of general anesthesia | |
Secondary | Diastolic blood pressure | Measured by mmHg from invasive arterial blood pressure | 3 minutes after induction | |
Secondary | Diastolic blood pressure | Measured by mmHg from invasive arterial blood pressure | Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure | |
Secondary | Left ventricular fractional shortening (LVFS) | measured in percentage derived from echocardiography | 12 hours before the operation | |
Secondary | Left ventricular fractional shortening (LVFS) | measured in percentage derived from echocardiography | 2 hours after the operation | |
Secondary | Left ventricular fractional shortening (LVFS) | measured in percentage derived from echocardiography | 4 hours after the operation | |
Secondary | Left ventricular fractional shortening (LVFS) | measured in percentage derived from echocardiography | 12 hours after the operation | |
Secondary | Left ventricular fractional shortening (LVFS) | measured in percentage derived from echocardiography | 24 hours after the operation | |
Secondary | Left ventricular fractional shortening (LVFS) | measured in percentage derived from echocardiography | 48 hours after the operation | |
Secondary | Left ventricular fractional shortening (LVFS) | measured in percentage derived from echocardiography | 72 hours after the operation | |
Secondary | Left ventricular ejection fraction (LVEF) | measured in percentage derived from echocardiography | 12 hours before the operation | |
Secondary | Left ventricular ejection fraction (LVEF) | measured in percentage derived from echocardiography | 2 hours after the operation | |
Secondary | Left ventricular ejection fraction (LVEF) | measured in percentage derived from echocardiography | 4 hours after the operation | |
Secondary | Left ventricular ejection fraction (LVEF) | measured in percentage derived from echocardiography | 12 hours after the operation | |
Secondary | Left ventricular ejection fraction (LVEF) | measured in percentage derived from echocardiography | 24 hours after the operation | |
Secondary | Left ventricular ejection fraction (LVEF) | measured in percentage derived from echocardiography | 48 hours after the operation | |
Secondary | Central venous pressure | from central venous catheter measured in cm H2O | Baseline 2 minutes after insertion of central venous catheter | |
Secondary | Central venous pressure | from central venous catheter measured in cm H2O | 2 minutes before cardiopulmonary bypass | |
Secondary | Central venous pressure | from central venous catheter measured in cm H2O | 2 minutes after cardiopulmonary bypass | |
Secondary | Central venous pressure | from central venous catheter measured in cm H2O | 1 minute after the end of operation | |
Secondary | Serum urea level | mmol/L | 5 minutes before beginning of operation | |
Secondary | Serum urea level | mmol/L | 5 minutes after ICU admission | |
Secondary | Serum creatinine level | mmol/L | 5 minutes before beginning of operation | |
Secondary | Serum creatinine level | mmol/L | 24 hours postoperatively | |
Secondary | Serum creatinine level | mmol/L | 48 hours postoperatively | |
Secondary | Serum creatinine level | mmol/L | 72 hours postoperatively | |
Secondary | Acute kidney injury (AKI) score | Grade 1: serum creatinine rise of 150%-200% of baseline and/or urine output <0.5 mL/kg/h for >6 contiguous hours.
Grade 2: serum creatinine rise of 200%-300% of baseline and/or urine output <0.5 mL/kg/h for >12 contiguous hours. Grade 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. |
24 hours postoperatively | |
Secondary | Acute kidney injury (AKI) score | Grade 1: serum creatinine rise of 150%-200% of baseline and/or urine output <0.5 mL/kg/h for >6 contiguous hours.
Grade 2: serum creatinine rise of 200%-300% of baseline and/or urine output <0.5 mL/kg/h for >12 contiguous hours. Grade 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. |
48 hours postoperatively | |
Secondary | Acute kidney injury (AKI) score | Grade 1: serum creatinine rise of 150%-200% of baseline and/or urine output <0.5 mL/kg/h for >6 contiguous hours.
Grade 2: serum creatinine rise of 200%-300% of baseline and/or urine output <0.5 mL/kg/h for >12 contiguous hours. Grade 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. |
72 hours postoperatively | |
Secondary | Serum sodium level | milliequivalent/L | 5 minutes after ICU admission. | |
Secondary | Serum sodium level | milliequivalent/L | 5 minutes before beginning of operation | |
Secondary | Serum potassium level | milliequivalent/L | 5 minutes before beginning of operation | |
Secondary | Serum potassium level | milliequivalent/L | 5 minutes after ICU admission | |
Secondary | Arterial oxygen pressure | From arterial blood gas sampling | 5 minutes before operation | |
Secondary | Arterial oxygen pressure | From arterial blood gas sampling | 2 minutes before cardiopulmonary bypass | |
Secondary | Arterial oxygen pressure | From arterial blood gas sampling | 2 minutes after cardiopulmonary bypass | |
Secondary | Arterial oxygen pressure | From arterial blood gas sampling | 1 minute after end of operation | |
Secondary | Arterial oxygen pressure | From arterial blood gas sampling | Every 6 hours for 24 hours in the ICU | |
Secondary | Arterial carbon dioxide pressure | From arterial blood gas sampling | 5 minutes before operation | |
Secondary | Arterial carbon dioxide pressure | From arterial blood gas sampling | 2 minutes before cardiopulmonary bypass | |
Secondary | Arterial carbon dioxide pressure | From arterial blood gas sampling | 2 minutes after cardiopulmonary bypass | |
Secondary | Arterial carbon dioxide pressure | From arterial blood gas sampling | 1 minute after end of operation | |
Secondary | Arterial carbon dioxide pressure | From arterial blood gas sampling | Every 6 hours for 24 hours in the ICU | |
Secondary | Power of hydrogen (pH) | From arterial blood gas sampling | 5 minutes before operation | |
Secondary | Power of hydrogen (pH) | From arterial blood gas sampling | 2 minutes before cardiopulmonary bypass | |
Secondary | Power of hydrogen (pH) | From arterial blood gas sampling | 2 minutes after cardiopulmonary bypass | |
Secondary | Power of hydrogen (pH) | From arterial blood gas sampling | 1 minute after end of operation | |
Secondary | Power of hydrogen (pH) | From arterial blood gas sampling | Every 6 hours for 24 hours in the ICU | |
Secondary | Standard bicarbonate level | From arterial blood gas sampling | 5 minutes before operation | |
Secondary | Standard bicarbonate level | From arterial blood gas sampling | 2 minutes before cardiopulmonary bypass | |
Secondary | Standard bicarbonate level | From arterial blood gas sampling | 2 minutes after cardiopulmonary bypass | |
Secondary | Standard bicarbonate level | From arterial blood gas sampling | 1 minute after end of operation | |
Secondary | Standard bicarbonate level | From arterial blood gas sampling | Every 6 hours for 24 hours in the ICU |
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