to Study the Effect of Vitamin C Administration on the Amount and the Time of Weaning of Noradrenaline Given Post-operatively to Patients After CPBNCT04519281
Role of Vitamin C in Cardiac Vasoplegia After Cardiopulmonary Bypass
An observational study of to Study the Effect of Vitamin C Administration on the Amount and the Time of Weaning of Noradrenaline Given Post-operatively to Patients After CPB, run by Cairo University at 1 site in Egypt.
Trial summary
This is a parallel group double-blind, randomized-controlled trial with 1:1 randomization ratio which will be conducted over a period of 6 months to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- to Study the Effect of Vitamin C Administration on the Amount and the Time of Weaning of Noradrenaline Given Post-operatively to Patients After CPB
- What is being tested?
- IV of vitamin C
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2020to 30 Oct 2020
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A parallel group double-blind, randomized-controlled trial, with 1:1 randomization ratio 2 groups will be included; * Group (A) consists of 50 patients undergoing open heart surgeries who will receive IV ascorbic acid. * Group (B) consists of 50 patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group).
Who may be able to join
- Patients undergoing cardiac surgeries with CPB having risk factors for cardiac vasoplegia like diabetes mellitus and chronic renal failure.
Who cannot join
- Patients who undergo surgeries without cardiopulmonary bypass (off-pump)
- Patients undergoing surgeries for congenital cardiac disease
- Patients performing heart transplantation and combined cardiac surgeries
- Patients with low pre-operative left ventricular ejection fraction (LVEF)
- Patients refusing to participate
- Patients who receive vasopressors other than noradrenaline
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11956
Noha Asem, MD, 00201003657120, kasralainirec@gmail.com
Soha Elmorsy, MD
About this study
Official title: Role of Preoperative IV Administration of Vitamin C in Patients at Risk for Cardiac Vasoplegia After Cardiopulmonary Bypass
This is a parallel group double-blind, randomized-controlled trial with 1:1 randomization ratio which will be conducted over a period of 6 months to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB. Two groups will be included; Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid (treatment group) and Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (control group). Each patient will be subjected to assessments of the doses of noradrenaline given from the end of surgery until weaning as well as hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery.
Read the detailed description
Background and Rationale:
Cardiac vasoplegia is a known phenomenon after cardiopulmonary bypass (CPB) occurring in up to 44% of patients. Severe forms of such condition refractory to vasopressors are associated with poor outcomes. New agents e.g. ascorbic acid that can alter the systemic vascular resistance in cardiac vasoplegia have been suggested as an attempt to avoid or at least reduce the use of IV vasopressors and their induced systemic hypo-perfusion.
Objectives :
- Primary objective: to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB
- Secondary objectives: to study the effect of vitamin C administration on the time to weaning from noradrenaline
Study population \& Sample size :
Patients undergoing cardiac surgeries with CPB having risk factors for cardiac vasoplegia like diabetes mellitus and chronic renal failure.
50 patients will be needed in each group (treatment and control)
Study Design :
A parallel group double-blind, randomized-controlled trial, with 1:1 randomization ratio 2 groups will be included;
-Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid. -Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group).
Methods :
Each patient will be subjected to the following assessments:
-Pre-operative patient characteristics: demographic data, co-morbidities, pre-operative echo findings,… -Intra-operative details: procedures, time parameters,… the doses of noradrenaline given from the end of surgery until weaning or death and hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery. -Postoperative data: echo parameters, patient outcome, time of discharge,…
Outcome parameter (s):
-Primary outcome: the area under the dose-time curve of noradrenaline -Secondary outcome measures: the duration of vasopressor (noradrenaline) infusion till weaning up to 3 days following surgery.
- Being tested
- IV of vitamin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV of vitamin CDrug
administration of high-dose of IV vitamin C perioperatively
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | consists of 50 patients undergoing open heart surgeries who will receive IV ascorbic acid Receives: Drug: IV of vitamin C | |
| Group (B) | consists of 50 patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of noradrenaline need
to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB
Measured: 3 days
Secondary outcomes (1)
duration of noradrenaline need
to study the effect of vitamin C administration on the time to weaning from noradrenaline
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start16 Apr 2020
- Primary completion15 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for to Study the Effect of Vitamin C Administration on the Amount and the Time of Weaning of Noradrenaline Given Post-operatively to Patients After CPBStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mostafa Ahmed Alkady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519281
- Sponsor's protocol ID
- N-17-2020
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Clinical outcomes are to be shared
Publications
Omar S, Zedan A, Nugent K. Cardiac vasoplegia syndrome: pathophysiology, risk factors and treatment. Am J Med Sci. 2015 Jan;349(1):80-8. doi: 10.1097/MAJ.0000000000000341.
PubMed 25247756Fischer GW, Levin MA. Vasoplegia during cardiac surgery: current concepts and management. Semin Thorac Cardiovasc Surg. 2010 Summer;22(2):140-4. doi: 10.1053/j.semtcvs.2010.09.007.
PubMed 21092891Wieruszewski PM, Nei SD, Maltais S, Schaff HV, Wittwer ED. Vitamin C for Vasoplegia After Cardiopulmonary Bypass: A Case Series. A A Pract. 2018 Aug 15;11(4):96-99. doi: 10.1213/XAA.0000000000000752.
PubMed 29634537
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Preoperative IV Administration of Vitamin C in Patients at Risk for Cardiac Vasoplegia After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT04519281
- Acronym / sponsor ID
- N-17-2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 19 Aug 2020 (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.
This is a parallel group double-blind, randomized-controlled trial with 1:1 randomization ratio which will be conducted over a period of 6 months to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB. Two groups will be included; Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid (treatment group) and Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (control group). Each patient will be subjected to assessments of the doses of noradrenaline given from the end of surgery until weaning as well as hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery.
Detailed description
Background and Rationale:
Cardiac vasoplegia is a known phenomenon after cardiopulmonary bypass (CPB) occurring in up to 44% of patients. Severe forms of such condition refractory to vasopressors are associated with poor outcomes. New agents e.g. ascorbic acid that can alter the systemic vascular resistance in cardiac vasoplegia have been suggested as an attempt to avoid or at least reduce the use of IV vasopressors and their induced systemic hypo-perfusion.
Objectives :
- Primary objective: to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB
- Secondary objectives: to study the effect of vitamin C administration on the time to weaning from noradrenaline
Study population \& Sample size :
Patients undergoing cardiac surgeries with CPB having risk factors for cardiac vasoplegia like diabetes mellitus and chronic renal failure.
50 patients will be needed in each group (treatment and control)
Study Design :
A parallel group double-blind, randomized-controlled trial, with 1:1 randomization ratio 2 groups will be included;
-Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid. -Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group).
Methods :
Each patient will be subjected to the following assessments:
-Pre-operative patient characteristics: demographic data, co-morbidities, pre-operative echo findings,… -Intra-operative details: procedures, time parameters,… the doses of noradrenaline given from the end of surgery until weaning or death and hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery. -Postoperative data: echo parameters, patient outcome, time of discharge,…
Outcome parameter (s):
-Primary outcome: the area under the dose-time curve of noradrenaline -Secondary outcome measures: the duration of vasopressor (noradrenaline) infusion till weaning up to 3 days following surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | – | Drug: IV of vitamin Cconsists of 50 patients undergoing open heart surgeries who will receive IV ascorbic acid |
| Group (B) | – | –consists of 50 patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group). |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A parallel group double-blind, randomized-controlled trial, with 1:1 randomization ratio 2 groups will be included; * Group (A) consists of 50 patients undergoing open heart surgeries who will receive IV ascorbic acid. * Group (B) consists of 50 patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group).
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgeries with CPB having risk factors for cardiac vasoplegia like diabetes mellitus and chronic renal failure.
Key exclusion criteria (6 listed)
- Patients who undergo surgeries without cardiopulmonary bypass (off-pump)
- Patients undergoing surgeries for congenital cardiac disease
- Patients performing heart transplantation and combined cardiac surgeries
- Patients with low pre-operative left ventricular ejection fraction (LVEF)
- Patients refusing to participate
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 |
|---|---|---|
| IV of vitamin Cadministration of high-dose of IV vitamin C perioperatively | Drug | Group (A) |
Primary outcome
amount of noradrenaline need
Time frame: 3 days
to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB
1 secondary outcome
duration of noradrenaline need
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Background: PubMed 25247756Omar S, Zedan A, Nugent K. Cardiac vasoplegia syndrome: pathophysiology, risk factors and treatment. Am J Med Sci. 2015 Jan;349(1):80-8. doi: 10.1097/MAJ.0000000000000341.
- Background: PubMed 21092891Fischer GW, Levin MA. Vasoplegia during cardiac surgery: current concepts and management. Semin Thorac Cardiovasc Surg. 2010 Summer;22(2):140-4. doi: 10.1053/j.semtcvs.2010.09.007.
- Background: PubMed 29634537Wieruszewski PM, Nei SD, Maltais S, Schaff HV, Wittwer ED. Vitamin C for Vasoplegia After Cardiopulmonary Bypass: A Case Series. A A Pract. 2018 Aug 15;11(4):96-99. doi: 10.1213/XAA.0000000000000752.
- Individual participant dataSharing planned: Undecided. Clinical outcomes are to be shared
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of to Study the Effect of Vitamin C Administration on the Amount and the Time of Weaning of Noradrenaline Given Post-operatively to Patients After CPB, run by Cairo 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Aug 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of noradrenaline need (time frame: 3 days). 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 NCT04519281, which also lists 3 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 19 Aug 2020.