Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160219
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2023-11-29
Brief Title:
Prophylactic Use of Hydroxycobolamin in Vasoplegic Syndrome in Adult Patients Undergoing Cardiopulmonary Bypass
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Prophylactic Use of Hydroxycobolamin in the Prevention of Vasoplegic Syndrome in Adult Patients Undergoing Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
Several studies have described the use of alternative drugs as methylene blue MB 3 other than the standard limited options of the use of vasopressors and systemic corticosteroids 4 especially in the face of increasing incidence of vasoplegic syndrome Hydroxycobolamin HCO has been used for treating cyanide poisoning for more than 40 years Persistant and significant hypertension occurred as a result of the ability of HCO to bind nitric oxide NO to form nitrocobalamin
In this prospective randomized controlled trial we hypothesized that the prophylactic use of HCO in high risk patients after CPB may decrease the incidence of vasoplegia
In this prospective randomized controlled trial we hypothesized that the prophylactic use of HCO in high risk patients after CPB may decrease the incidence of vasoplegia
Detailed Description:
Patients and methods
This randomized placebo-controlled single -center study will be conducted in Ain Shams University Hospital from May 2019 till October 2022 Patients undergoing Cardiopulmonary bypass grafting CABG andor valve surgery will be approached by their anesthesia providers Those who will be accepted to participate in the study were screened for inclusion and exclusion criteria on the day of the surgery or one day before Informed consent will be taken from all participants by anesthesia providers The duration of the study will be from the start of cardiac surgical procedure till after separation from CPB by 60 minutes
Patients will be included in the study are aged from18- 60 yrs old undergoing CABG andor valve surgery on CPB and have 2 or more preoperative risk factors for Vasoplegia including
Using preoperative beta blocker BB or Angiotensin converting enzyme inhibitor ACEI
preoperative EF 35
History of thyroid disease
Preoperative diuretics
Exclusion criteria are
1 Emergency surgery
2 Severe renal Insufficiency preoperative Cr 18 mg dL
3 Severe hepatic disease preoperative diagnosis of liver cirrhosis or recent elevated liver function tests
4 Pregnant or woman of child bearing potential
5 Know hypersensitivity to hydroxycobolamin
Preoperative data will be obtained from the medical records and verified with the patients sex age Body surface index BSI height and weight type of surgery preoperative use of ACEI- BB- calcium channel blocker CCB - amiodarone mean arterial blood pressure MAP preoperative Ejection fraction EF Anesthesia will be induced in all patients and maintained by using midazolam fentanyl propofol sevoflurane pancurium
All patients were monitored with the routine monitoring of all cardiac patients which included MAP in mmHg oxygen saturation SaO2 central venous pressure CVP in cmH2o electrocardiography ECG Cardiac output CO Lmin arterial blood gases ABG measuring PH PaCo2 HCO3 lactate during the pre- during- post CPB trans-esophageal echocardiography TEE measuring CO CI LVEF SVR dynescm5MAP-CVPCO 800 SVRI MAP-CVP CI 800
Vasopressors in the form of norepinephrine will be started and titrated to maintain MAP 60 mmHg in the pre- during - post CPB period
The total doses of norepinephrine and epinephrine if needed in µgkgmin will be recorded on the anesthesia record by anesthesia providers After induction of CPB all patients undergo non pulsatile hypothermia 32-34 0C CPB with a membrane oxygenator and the arterial line filter Priming of CPB will be done by crystalloids and serial HCT level were at 18 The flow rate on CPB was 2- 25L min m2 to maintain the MAP 50-80 mmHg Blood gases samples will be measured every 30 min to maintain arterial CO2 of 35-40 mmHg uncorrected for temperature alpha stat and the partial pressure of O2 150-250 mmHg Hemodynamics will be recorded every 30 min intervals and stored into the anesthesia record The time of CPB and cross clamping time will be recorded
At the end of CPB the patients will be assigned randomly into 2 groups by using computer generated random numbers sequences and sealed envelopes
Group OH CO 30 patients will receive hydroxycobolamin Cyanokit 5 gm intravenouslyiv through the central venous catheter as bolus over 15 min reconstituted in 200 ml of NS
Group C control 30 patients will receive 200ml of NS over 15 min iv
Primary outcome will be change in MAP between baseline and all time points 30 60 min after CPB initiation and 30 60 min after CPB separation between the two groups and within the same group
Secondary outcomes were
1 Change in SVR between baseline and all time points 30 60 min after CPB initiation and 30 60 min after CPB separation between the 2 groups and within the same group
2 Number of patients who needed norepinephrine 05µgkgmin epinephrine as inotropic support during weaning from CPB
3 Incidence of vasoplegic syndrome occurrence which is defined as occurrence of one or more of these parameters systemic vascular resistance of 800 dyne s cm an MAP of 60 to 65 mm Hg a cardiac index of 25 to 3 L min m2 a requirement for at least one or more high-dose of vasopressors ie norepinephrine 005 μg kg min
4 Number of patients who developed norepinephrine refractory vasoplegia needed epinephrine as another inotropic support
5 Number of patients developed multiorgan failure in ICU
6 Mortality rate
This randomized placebo-controlled single -center study will be conducted in Ain Shams University Hospital from May 2019 till October 2022 Patients undergoing Cardiopulmonary bypass grafting CABG andor valve surgery will be approached by their anesthesia providers Those who will be accepted to participate in the study were screened for inclusion and exclusion criteria on the day of the surgery or one day before Informed consent will be taken from all participants by anesthesia providers The duration of the study will be from the start of cardiac surgical procedure till after separation from CPB by 60 minutes
Patients will be included in the study are aged from18- 60 yrs old undergoing CABG andor valve surgery on CPB and have 2 or more preoperative risk factors for Vasoplegia including
Using preoperative beta blocker BB or Angiotensin converting enzyme inhibitor ACEI
preoperative EF 35
History of thyroid disease
Preoperative diuretics
Exclusion criteria are
1 Emergency surgery
2 Severe renal Insufficiency preoperative Cr 18 mg dL
3 Severe hepatic disease preoperative diagnosis of liver cirrhosis or recent elevated liver function tests
4 Pregnant or woman of child bearing potential
5 Know hypersensitivity to hydroxycobolamin
Preoperative data will be obtained from the medical records and verified with the patients sex age Body surface index BSI height and weight type of surgery preoperative use of ACEI- BB- calcium channel blocker CCB - amiodarone mean arterial blood pressure MAP preoperative Ejection fraction EF Anesthesia will be induced in all patients and maintained by using midazolam fentanyl propofol sevoflurane pancurium
All patients were monitored with the routine monitoring of all cardiac patients which included MAP in mmHg oxygen saturation SaO2 central venous pressure CVP in cmH2o electrocardiography ECG Cardiac output CO Lmin arterial blood gases ABG measuring PH PaCo2 HCO3 lactate during the pre- during- post CPB trans-esophageal echocardiography TEE measuring CO CI LVEF SVR dynescm5MAP-CVPCO 800 SVRI MAP-CVP CI 800
Vasopressors in the form of norepinephrine will be started and titrated to maintain MAP 60 mmHg in the pre- during - post CPB period
The total doses of norepinephrine and epinephrine if needed in µgkgmin will be recorded on the anesthesia record by anesthesia providers After induction of CPB all patients undergo non pulsatile hypothermia 32-34 0C CPB with a membrane oxygenator and the arterial line filter Priming of CPB will be done by crystalloids and serial HCT level were at 18 The flow rate on CPB was 2- 25L min m2 to maintain the MAP 50-80 mmHg Blood gases samples will be measured every 30 min to maintain arterial CO2 of 35-40 mmHg uncorrected for temperature alpha stat and the partial pressure of O2 150-250 mmHg Hemodynamics will be recorded every 30 min intervals and stored into the anesthesia record The time of CPB and cross clamping time will be recorded
At the end of CPB the patients will be assigned randomly into 2 groups by using computer generated random numbers sequences and sealed envelopes
Group OH CO 30 patients will receive hydroxycobolamin Cyanokit 5 gm intravenouslyiv through the central venous catheter as bolus over 15 min reconstituted in 200 ml of NS
Group C control 30 patients will receive 200ml of NS over 15 min iv
Primary outcome will be change in MAP between baseline and all time points 30 60 min after CPB initiation and 30 60 min after CPB separation between the two groups and within the same group
Secondary outcomes were
1 Change in SVR between baseline and all time points 30 60 min after CPB initiation and 30 60 min after CPB separation between the 2 groups and within the same group
2 Number of patients who needed norepinephrine 05µgkgmin epinephrine as inotropic support during weaning from CPB
3 Incidence of vasoplegic syndrome occurrence which is defined as occurrence of one or more of these parameters systemic vascular resistance of 800 dyne s cm an MAP of 60 to 65 mm Hg a cardiac index of 25 to 3 L min m2 a requirement for at least one or more high-dose of vasopressors ie norepinephrine 005 μg kg min
4 Number of patients who developed norepinephrine refractory vasoplegia needed epinephrine as another inotropic support
5 Number of patients developed multiorgan failure in ICU
6 Mortality rate
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?:
False
Is an FDA AA801 Violation?:
None