Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414330
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus HTK Solution Cardioplegia Solution in Cardiac Surgery
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Ringer Acetate Based Modified Del Nido Cardioplegia Solution Versus Histidine Tryptophan and Ketoglutarate Solution Cardioplegia Solution in Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HTK
Brief Summary:
Low chloride solutions were proved to be better in resuscitation of emergency cases and decrease the resulting hyperchloremic metabolic acidosis in the last decade In ringers acetate solutions there is acetate which is metabolized in muscles to produce bicarbonate molecules so neutralizing the ongoing lactic and hyperchloremic metabolic solutions Both solutions were proved to be superior to normal saline as a fluid therapy plan in most studies with much less ongoing hyperchloremic metabolic acidosis and inflammatory response In this protocol modified Del Nido formula will be involved using ringers acetate instead of plasmalyte solutions and comparing the effects on myocardial protection versus HTK solutions
Detailed Description:
First fulfilling all inclusion criteria and consent acceptance for study are to be confirmed Preoperative evaluation is done for full laboratory investigations including CBC coagulation renal and liver functions CRP and troponin full clinical examination for chest and heart coronary angiography Echocardiography carotid doppler and upper and lower venous and arterial doppler are to be done All patients will be scheduled for on pump CABG surgery Low dose of midazolam will be given before surgery Intraoperative monitoring will involve invasive blood pressure ECG peripheral pulse oximetry capnogram
After induction of anaesthesia and median sternotomy patients will be randomly allocated into two groups
Group D will receive modified Del Nido cardioplegia Ringer acetate 1000ml mannitol 20 17 ml magnesium sulphate 10 20ml sodium bicarbonate 84 16ml potassium chloride 75 13ml and lidocaine 2 8 ml Crystalloid to blood ratio will be 80 to 20 respectively Dose will be 15 - 20 mlkg in first dose then 8 - 10 mlkg every 60 minutes
Group C will receive HTK Histidine Tryptophan and Ketoglutarate solution consisting of 1000ml distilled water sodium 15mmolL potassium 9mmolL magnesium 4mmolL calcium 0015 mmolL histidine 129mmolL tryptophan 2mmolL ketoglutarate 1mmolL mannitol 30mmol and pH 702 - 12 Dose will be 10 - 20 mlkg and can be repeated once after 120 minutes
All patients will receive hypothermia 29 - 32 and cardioplegia will be injected between the aortic valve and aortic cross clamp in a pressure not less than 50 mmHg above systolic pressure After removal of aortic cross clamping the heart will be monitored for ventricular arrhythmias early recovery and postoperative 24 hours serum troponin and new changes in echocardiography
After induction of anaesthesia and median sternotomy patients will be randomly allocated into two groups
Group D will receive modified Del Nido cardioplegia Ringer acetate 1000ml mannitol 20 17 ml magnesium sulphate 10 20ml sodium bicarbonate 84 16ml potassium chloride 75 13ml and lidocaine 2 8 ml Crystalloid to blood ratio will be 80 to 20 respectively Dose will be 15 - 20 mlkg in first dose then 8 - 10 mlkg every 60 minutes
Group C will receive HTK Histidine Tryptophan and Ketoglutarate solution consisting of 1000ml distilled water sodium 15mmolL potassium 9mmolL magnesium 4mmolL calcium 0015 mmolL histidine 129mmolL tryptophan 2mmolL ketoglutarate 1mmolL mannitol 30mmol and pH 702 - 12 Dose will be 10 - 20 mlkg and can be repeated once after 120 minutes
All patients will receive hypothermia 29 - 32 and cardioplegia will be injected between the aortic valve and aortic cross clamp in a pressure not less than 50 mmHg above systolic pressure After removal of aortic cross clamping the heart will be monitored for ventricular arrhythmias early recovery and postoperative 24 hours serum troponin and new changes in echocardiography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None