Lactic AcidosisRIPCNCT03723993
Remote Ischemic Preconditioning During Cardiopulmonary Bypass
A study testing Inflated cuff and Non inflated cuff in people with Lactic Acidosis, run by Fayoum University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lactic Acidosis
- What is being tested?
- Inflated cuff and Non inflated cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 15 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Elective cardiovascular surgery requiring cardiopulmonary bypass either for CABG or valve replacement.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remote Ischemic Preconditioning on Serum Lactate Levels As Well As Cardiac and Renal Functions During and After Open Heart Surgeries
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.
Read the detailed description
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.
RIPC 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.
ANESTHETIC 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).
Patient 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).
Trachea 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.
For drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein.
Anesthesia 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.
During extracorporeal circulation, patients will receive propofol infusion in addition to atracurium infusion.
Before 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.
After 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.
- Conditions
- Lactic Acidosis
- Being tested
- Inflated cuff, Non inflated cuff
- Keywords
- Ischemic preconditioning, Lactate level, Cardiopulmonary bypass
- Medical subject headings
- Acidosis, Lactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflated cuffDevice
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
Non inflated cuffDevice
non inflated cuff around the arm for the control group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | control group will have non inflated cuff around the arm. Receives: Device: Non inflated cuff |
| RIPC group | Active comparator | Inflated cuff will be done systematically and regularly Receives: Device: Inflated cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lactate level
mmol/l from arterial blood gas sample
Measured: 1 minute at the end of operation
Secondary outcomes (65)
Serum lactate level
mmol/l from arterial blood gas sample
Measured: 3 minutes after induction of anesthesia
Serum lactate level
mmol/l from arterial blood gas sample
Measured: 30 minutes, after cardiopulmonary bypass
Serum lactate level
mmol/l from arterial blood gas sample
Measured: 1 minute before cardiopulmonary bypass
Serum lactate level
mmol/l from arterial blood gas sample
Measured: 24 hours postoperatively.
Serum lactate level
mmol/l from arterial blood gas sample
Measured: 48 hours postoperatively.
Serum lactate level
mmol/l from arterial blood gas sample
Measured: 72 hours postoperatively.
Heart rate
beat per minute from electrocardiogram
Measured: 2 minutes before induction of general anesthesia
Heart rate
beat per minute from electrocardiogram
Measured: 3 minutes after induction of general anesthesia
Heart rate
beat per minute from electrocardiogram
Measured: Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia
Systolic blood pressure
Measured by mmHg from invasive arterial blood pressure
Measured: 2 minutes before induction of general anesthesia
Systolic blood pressure
Measured by mmHg from invasive arterial blood pressure
Measured: 3 minutes after induction
Systolic blood pressure
Measured by mmHg from invasive arterial blood pressure
Measured: Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure
Diastolic blood pressure
Measured by mmHg from invasive arterial blood pressure
Measured: 2 minutes before induction of general anesthesia
Diastolic blood pressure
Measured by mmHg from invasive arterial blood pressure
Measured: 3 minutes after induction
Diastolic blood pressure
Measured by mmHg from invasive arterial blood pressure
Measured: Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure
Left ventricular fractional shortening (LVFS)
measured in percentage derived from echocardiography
Measured: 12 hours before the operation
Left ventricular fractional shortening (LVFS)
measured in percentage derived from echocardiography
Measured: 2 hours after the operation
Left ventricular fractional shortening (LVFS)
measured in percentage derived from echocardiography
Measured: 4 hours after the operation
Left ventricular fractional shortening (LVFS)
measured in percentage derived from echocardiography
Measured: 12 hours after the operation
Left ventricular fractional shortening (LVFS)
measured in percentage derived from echocardiography
Measured: 24 hours after the operation
Left ventricular fractional shortening (LVFS)
measured in percentage derived from echocardiography
Measured: 48 hours after the operation
Left ventricular fractional shortening (LVFS)
measured in percentage derived from echocardiography
Measured: 72 hours after the operation
Left ventricular ejection fraction (LVEF)
measured in percentage derived from echocardiography
Measured: 12 hours before the operation
Left ventricular ejection fraction (LVEF)
measured in percentage derived from echocardiography
Measured: 2 hours after the operation
Left ventricular ejection fraction (LVEF)
measured in percentage derived from echocardiography
Measured: 4 hours after the operation
Left ventricular ejection fraction (LVEF)
measured in percentage derived from echocardiography
Measured: 12 hours after the operation
Left ventricular ejection fraction (LVEF)
measured in percentage derived from echocardiography
Measured: 24 hours after the operation
Left ventricular ejection fraction (LVEF)
measured in percentage derived from echocardiography
Measured: 48 hours after the operation
Central venous pressure
from central venous catheter measured in cm H2O
Measured: Baseline 2 minutes after insertion of central venous catheter
Central venous pressure
from central venous catheter measured in cm H2O
Measured: 2 minutes before cardiopulmonary bypass
Central venous pressure
from central venous catheter measured in cm H2O
Measured: 2 minutes after cardiopulmonary bypass
Central venous pressure
from central venous catheter measured in cm H2O
Measured: 1 minute after the end of operation
Serum urea level
mmol/L
Measured: 5 minutes before beginning of operation
Serum urea level
mmol/L
Measured: 5 minutes after ICU admission
Serum creatinine level
mmol/L
Measured: 5 minutes before beginning of operation
Serum creatinine level
mmol/L
Measured: 24 hours postoperatively
Serum creatinine level
mmol/L
Measured: 48 hours postoperatively
Serum creatinine level
mmol/L
Measured: 72 hours postoperatively
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.
Measured: 24 hours postoperatively
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.
Measured: 48 hours postoperatively
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.
Measured: 72 hours postoperatively
Serum sodium level
milliequivalent/L
Measured: 5 minutes after ICU admission.
Serum sodium level
milliequivalent/L
Measured: 5 minutes before beginning of operation
Serum potassium level
milliequivalent/L
Measured: 5 minutes before beginning of operation
Serum potassium level
milliequivalent/L
Measured: 5 minutes after ICU admission
Arterial oxygen pressure
From arterial blood gas sampling
Measured: 5 minutes before operation
Arterial oxygen pressure
From arterial blood gas sampling
Measured: 2 minutes before cardiopulmonary bypass
Arterial oxygen pressure
From arterial blood gas sampling
Measured: 2 minutes after cardiopulmonary bypass
Arterial oxygen pressure
From arterial blood gas sampling
Measured: 1 minute after end of operation
Arterial oxygen pressure
From arterial blood gas sampling
Measured: Every 6 hours for 24 hours in the ICU
Arterial carbon dioxide pressure
From arterial blood gas sampling
Measured: 5 minutes before operation
Arterial carbon dioxide pressure
From arterial blood gas sampling
Measured: 2 minutes before cardiopulmonary bypass
Arterial carbon dioxide pressure
From arterial blood gas sampling
Measured: 2 minutes after cardiopulmonary bypass
Arterial carbon dioxide pressure
From arterial blood gas sampling
Measured: 1 minute after end of operation
Arterial carbon dioxide pressure
From arterial blood gas sampling
Measured: Every 6 hours for 24 hours in the ICU
Power of hydrogen (pH)
From arterial blood gas sampling
Measured: 5 minutes before operation
Power of hydrogen (pH)
From arterial blood gas sampling
Measured: 2 minutes before cardiopulmonary bypass
Power of hydrogen (pH)
From arterial blood gas sampling
Measured: 2 minutes after cardiopulmonary bypass
Power of hydrogen (pH)
From arterial blood gas sampling
Measured: 1 minute after end of operation
Power of hydrogen (pH)
From arterial blood gas sampling
Measured: Every 6 hours for 24 hours in the ICU
Standard bicarbonate level
From arterial blood gas sampling
Measured: 5 minutes before operation
Standard bicarbonate level
From arterial blood gas sampling
Measured: 2 minutes before cardiopulmonary bypass
Standard bicarbonate level
From arterial blood gas sampling
Measured: 2 minutes after cardiopulmonary bypass
Standard bicarbonate level
From arterial blood gas sampling
Measured: 1 minute after end of operation
Standard bicarbonate level
From arterial blood gas sampling
Measured: Every 6 hours for 24 hours in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start15 Jan 2018
- Primary completion15 Nov 2018 (estimated)
- Study completion15 Dec 2018 (estimated)
Why it stopped: Finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lactic AcidosisStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University
- Investigators
- Mohamed A Hamed, MD, Principal investigator, Faculty of medicine, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723993
- Sponsor's protocol ID
- R123
- Acronym
- RIPC
- Status last verified
- Feb 2021
- First submitted
- 26 Oct 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19549044Heusch 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.
PubMed 23095318Thielmann 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.
PubMed 23953384Badreldin 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.
PubMed 24338631
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Serum Lactate Levels As Well As Cardiac and Renal Functions During and After Open Heart Surgeries
- ClinicalTrials.gov ID
- NCT03723993
- Acronym / sponsor ID
- RIPC / R123
- Conditions
- Lactic Acidosis
- Keywords
- Ischemic preconditioning, Lactate level, Cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Finished
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Nov 2018 (estimated)
- Study completion
- 15 Dec 2018 (estimated)
- First posted
- 30 Oct 2018 (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.
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.
Detailed description
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.
RIPC 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.
ANESTHETIC 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).
Patient 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).
Trachea 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.
For drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein.
Anesthesia 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.
During extracorporeal circulation, patients will receive propofol infusion in addition to atracurium infusion.
Before 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.
After 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Non inflated cuffcontrol group will have non inflated cuff around the arm. |
| RIPC group | Active comparator | Device: Inflated cuffInflated cuff will be done systematically and regularly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Elective cardiovascular surgery requiring cardiopulmonary bypass either for CABG or valve replacement.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Inflated cuffAfter 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 | Device | RIPC group |
| Non inflated cuffnon inflated cuff around the arm for the control group | Device | Control group |
Primary outcome
Serum lactate level
Time frame: 1 minute at the end of operation
mmol/l from arterial blood gas sample
65 secondary outcomes
Serum lactate level
Time frame: 3 minutes after induction of anesthesia
Serum lactate level
Time frame: 30 minutes, after cardiopulmonary bypass
Serum lactate level
Time frame: 1 minute before cardiopulmonary bypass
Serum lactate level
Time frame: 24 hours postoperatively.
Serum lactate level
Time frame: 48 hours postoperatively.
Serum lactate level
Time frame: 72 hours postoperatively.
Heart rate
Time frame: 2 minutes before induction of general anesthesia
Heart rate
Time frame: 3 minutes after induction of general anesthesia
Heart rate
Time frame: Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia
Systolic blood pressure
Time frame: 2 minutes before induction of general anesthesia
Systolic blood pressure
Time frame: 3 minutes after induction
Systolic blood pressure
Time frame: Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure
Diastolic blood pressure
Time frame: 2 minutes before induction of general anesthesia
Diastolic blood pressure
Time frame: 3 minutes after induction
Diastolic blood pressure
Time frame: Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure
Left ventricular fractional shortening (LVFS)
Time frame: 12 hours before the operation
Left ventricular fractional shortening (LVFS)
Time frame: 2 hours after the operation
Left ventricular fractional shortening (LVFS)
Time frame: 4 hours after the operation
Left ventricular fractional shortening (LVFS)
Time frame: 12 hours after the operation
Left ventricular fractional shortening (LVFS)
Time frame: 24 hours after the operation
Left ventricular fractional shortening (LVFS)
Time frame: 48 hours after the operation
Left ventricular fractional shortening (LVFS)
Time frame: 72 hours after the operation
Left ventricular ejection fraction (LVEF)
Time frame: 12 hours before the operation
Left ventricular ejection fraction (LVEF)
Time frame: 2 hours after the operation
Left ventricular ejection fraction (LVEF)
Time frame: 4 hours after the operation
Left ventricular ejection fraction (LVEF)
Time frame: 12 hours after the operation
Left ventricular ejection fraction (LVEF)
Time frame: 24 hours after the operation
Left ventricular ejection fraction (LVEF)
Time frame: 48 hours after the operation
Central venous pressure
Time frame: Baseline 2 minutes after insertion of central venous catheter
Central venous pressure
Time frame: 2 minutes before cardiopulmonary bypass
Central venous pressure
Time frame: 2 minutes after cardiopulmonary bypass
Central venous pressure
Time frame: 1 minute after the end of operation
Serum urea level
Time frame: 5 minutes before beginning of operation
Serum urea level
Time frame: 5 minutes after ICU admission
Serum creatinine level
Time frame: 5 minutes before beginning of operation
Serum creatinine level
Time frame: 24 hours postoperatively
Serum creatinine level
Time frame: 48 hours postoperatively
Serum creatinine level
Time frame: 72 hours postoperatively
Acute kidney injury (AKI) score
Time frame: 24 hours postoperatively
Acute kidney injury (AKI) score
Time frame: 48 hours postoperatively
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 3 Feb 2021.
- Background: PubMed 19549044Saxena 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.
- Background: PubMed 23095318Heusch 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.
- Background: PubMed 23953384Thielmann 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.
- Background: PubMed 24338631Badreldin 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.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed A Hamed, MD principal investigator
Faculty of medicine, Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflated cuff and Non inflated cuff in people with Lactic Acidosis, run by Fayoum University at 1 site in Egypt.
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 7 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 3 Feb 2021. 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 Egypt. 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?
Serum lactate level (time frame: 1 minute at the end of operation). 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 NCT03723993, which also lists 4 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 3 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.