Cardiac SurgeryNorcalNCT04312971
Norepinephrine Infusion During Cardiopulmonary Bypass
A study testing Norepinephrine, Increase infusion rate and Decrease infusion rate in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
Trial summary
The primary objective is to test the efficacy and safety of the accuracy of continuous intravenous infusion of norepinephrine during cardiopulmonary bypass (CPB) on the prevention of hyperlactatemia after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass
- What is being tested?
- Norepinephrine, Increase infusion rate and Decrease infusion rate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 6 May 2020to 20 Sep 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status between ІІІ and ІV
- Scheduled for any type of elective cardiac surgery using CPB
- General anesthesia provided in an endotracheally intubated patient.
Who cannot join
- Decline consent to participate.
- Emergency surgery.
- Ejection fraction (EF%) less than 35%.
- Scheduled for re-do surgery.
- Scheduled for emergency surgery.
- Preoperative ventilator or circulatory support.
Show all 12Show fewer
- Body mass index (BMI) greater than 40 Kg/m2.
- History of alcohol abuse.
- History of drug abuse.
- Pregnancy.
- Consent for another interventional study during anaesthesia
- No written informed consent.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Imam Abdulrahamn Bin Faisal University (Former, Dammam University)
Dammam, Esatern, 31952
Dammam University
Khobar, Eastern Province, 31952
About this study
Official title: Effects of Norepinephrine Infusion During Cardiopulmonary Bypass on Perioperative Changes in Lactic Acid Level: A Randomized Controlled Study
The primary objective is to test the efficacy and safety of the accuracy of continuous intravenous infusion of norepinephrine during cardiopulmonary bypass (CPB) on the prevention of hyperlactatemia after cardiac surgery.
"Efficacy" would be tested with measurement of the postoperative changes in lactic acid level over time from the baseline value before induction of general anesthesia.
"safety" would be tested with observing the post-cardiotomy need for inotropic and vasopressor support, the incidence of postoperative acute kidney injury (AKI), changes in cardiac troponin level (CnTnI), and signs of ischemic splanchnic injury.
Read the detailed description
Rationale
1.1. Vasoplegia and cardiac surgery:
Vasoplegia Syndrome (VS), prevailing in about 20% of cardiac surgical procedures (1), is defined as low mean arterial pressure (MAP) with normal or high cardiac indices and which is resistant to treatment with the commonly used vasopressors. (2,3) Vasoplegia might occur either during or after the cardiopulmonary bypass periods or during the postoperative period during the intensive care unit (ICU) stay. (3) Many factors have been found to be related to the increased Vasoplegia during the cardiopulmonary bypass period such as left ventricular ejection fraction more than 40%, male patients, elderly patients, higher body mass index, long cardiopulmonary bypass time, hypotension upon the start of cardiopulmonary bypass, perioperative use of angiotensin-converting enzyme inhibitors (ACE) and presence of infective endocarditis. (4,5)
1.2. Effects of Cardiopulmonary bypass (CPB) on Post cardiotomy Vasoplegia.
Cardiopulmonary bypass itself may intensify the effects of vasoplegia due to hemodilution which decreases the blood viscosity, so, reducing the overall peripheral vascular resistance. Moreover, the interaction of blood with the tubing of the cardiopulmonary bypass machine results in the release of inflammatory mediators which play an important role in reducing the peripheral resistance and aggravating the hypotension. Although compensatory and auto-regulatory mechanisms play an important role in maintaining adequate tissue perfusion, hypotension during the cardiopulmonary bypass period may result in poor outcomes as postoperative stroke (4) especially if the mean arterial pressure is below 65 mmHg. (6)
1.3. Hyperlactatemia after cardiac surgery
Lactate was used as a marker for adequate tissue perfusion since the mid-1800s. Although the literature has illustrated the undesirable effects of high lactate levels, however, the cause, the prevention as well as treatment measures of hyperlactatemia remain obscure. Additionally, lactic acidosis or hyperlactatemia might occur in cases of refractory vasoplegia. A rise in lactate levels is common during cardiac surgery and is well known for its deleterious and its association with poor patients' outcomes. (7)
Owing to its detrimental effects, measures to reduce the effects and treat vasoplegia were used. Firstly, excluding any equipment or mechanical failure such as the arterial line monitor, adjusting the bypass flows for higher cardiac index (CI>2.2), confirming the proper cannula position and ruling out any aortic dissection.
Secondly, adjusting some physiological parameters is of great value as checking hematocrit level for excessive hemodilution, adjusting the anesthetics with severe vasodilatory properties, excluding the possibility of a drug reaction or anaphylaxis and temperature management during hypothermic bypass.
Thirdly, the use of conventional vasopressor agents as phenylephrine, norepinephrine, and vasopressin. Finally, the use of some off-label agents as vitamin C, hydroxocobalamin, angiotensin 2, methylene blue and prostaglandin inhibitors. (8)
1.4. Why this clinical trial?
The use of norepinephrine during CPB has its own potential benefits. It is not clear if the use of continuous norepinephrine infusion during CPB would be effective and safe in lessening the postoperative hyperlactatemia and development of vasoplegia after cardiac surgery.
The here proposed randomized controlled clinical trial will test the use of continuous norepinephrine infusion during CPB with respect to the efficacy and safety to reduce the postoperative rise in blood lactate level.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Being tested
- Placebo, Norepinephrine, Increase infusion rate, Decrease infusion rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Patients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of Normal Saline 0.9% with a starting dose of 0.0025 ml/kg/min.
NorepinephrineDrug
Patients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of norepinephrine (40 ug/ml) with a starting dose of 0.0025 ml/kg/min.
Increase infusion rateOther
Infusion rate will be increased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min increments
Decrease infusion rateOther
Infusion rate will be decreased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min decrements
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Infusion of normal Saline 0.9%will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time. Receives: Drug: Placebo; Other: Increase infusion rate; Other: Decrease infusion rate |
| Norepinephrine | Active comparator | Infusion of norepinephrine (40 µg/ml) will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time. Receives: Drug: Norepinephrine; Other: Increase infusion rate; Other: Decrease infusion rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lactic acid level
perioperative changes in lactic acid level measured from arterial or venous blood
Measured: For 24 hours after surgery from the start of surgery
Secondary outcomes (43)
Mean Arterial Pressure (MAP)
invasive arterial blood pressure measurement
Measured: For 24 hours after surgery from the start of surgery
Cardiac Index (CI)
measured as l/min/m2
Measured: For 24 hours after surgery from the start of surgery
Systemic Vascular Resistance index (SVRI)
measured as dynes.sec.m2/cm5
Measured: For 24 hours after surgery from the start of surgery
Stroke volume variation (SVV)
measured as ml/min/m2
Measured: For 24 hours after surgery from the start of surgery
Need for rescue doses of phenylephrine
Use of rescue doses of phenylephrine
Measured: For the time of surgery
Need for rescue doses of norepinephrine
Use of rescue doses of norepinephrine
Measured: For the time of surgery
Need for rescue doses of ephedrine
Use of rescue doses of ephedrine
Measured: For the time of surgery
Need for rescue doses of nitroglycerine
Use of rescue doses of nitroglycerine
Measured: For the time of surgery
Need for rescue doses of labetalol
Use of rescue doses of labetalol
Measured: For the time of surgery
Need for rescue doses of esmolol
Use of rescue doses of esmolol
Measured: For the time of surgery
Need for rescue doses of atropine
Use of rescue doses of atropine
Measured: For the time of surgery
Need for rescue doses of glycopyrrolate.
Use of rescue doses of glycopyrrolate
Measured: For the time of surgery
Intraoperative hypoxemia
Decrease of peripheral oxygen saturation less than 92%
Measured: For the time of surgery
Intraoperative hypercapnia
Increase in end tidal carbon dioxide more than 45 mm Hg
Measured: For the time of surgery
Intraoperative hypotension
Number of drops in systolic arterial pressure < 90 mmHg for 3 minutes or longer for any reasons
Measured: For the time of surgery
Intraoperative bradycardia
Number of drops in heart rate lower than 40 beats.min-1 or 10% of baseline value for more than three minutes for any reasons.
Measured: For the time of surgery
Intraoperative myocardial ischemic episodes
Remarkable ischemic changes included those patients with ≥ 1- mv ST-segment depression or ≥ 2-mv ST-segment elevation lasting more than 1 minute
Measured: For the time of surgery
Number of patients who required pacemaker insertion
Need for pacemaker insertion following termination of cardiopulmonary bypass.
Measured: For the time of surgery
Number of patients who required direct current shocks
Need for direct current shock following termination of cardiopulmonary bypass..
Measured: For the time of surgery
Number of patients who need for epinephrine
Need for epinephrine following termination of cardiopulmonary bypass.
Measured: For the time of surgery
Number of patients who need for norepinephrine
Need for norepinephrine following termination of cardiopulmonary bypass.
Measured: For the time of surgery
Number of patients who need for dobutamine
Need for dobutamine following termination of cardiopulmonary bypass.
Measured: For the time of surgery
Number of patients who need for milrinone
Need for milrinone following termination of cardiopulmonary bypass.
Measured: For the time of surgery
Number of patients who need for for Intra-Aortic Balloon Pump
Need for intra-aortic balloon counter pulsation pump following termination of cardiopulmonary bypass.
Measured: For the time of surgery
Intraoperative need for blood transfusion
The amount of transfused units of blood and blood products
Measured: For the time of surgery
Intraoperative fluid intake
The amount of infused crystalloids and colloids
Measured: For the time of surgery
ICU Stay
Length of ICU stay
Measured: For 30 days after surgery
Hospital Stay
Length of hospital stay
Measured: For 30 days after surgery
Mortality at 30 days
Alive or dead on postoperative day 30
Measured: For 30 days after surgery
Mortality at 90 days
Alive or dead on postoperative day 90
Measured: For 90 days after surgery
Postoperative need for reintubation
Postoperative need for reintubation during the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative bleeding
Postoperative bleeding during the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative cardiogenic shock
Postoperative cariogenic shock for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative acute kidney injury
Postoperative acute kidney injury for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative splanchnic ischemia
Postoperative mesenteric or splanchnic ischemia for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative myocardial ischemia
Postoperative acute coronary syndrome for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative wound infection
Postoperative wound infection for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative pneumonia
Postoperative pneumonia for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative mediastinitis
Postoperative mediastinitis for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative hypoxemia
Postoperative decrease in peripheral oxygen saturation less than 90 for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative stroke
Postoperative stroke for the first 30 days following surgery
Measured: For 30 days after surgery
Postoperative sternotomy
Postoperatively during hospital stay
Measured: For 30 days after surgery
Postoperative sternal dehiscence
Postoperatively during hospital stay
Measured: For 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start6 May 2020
- Primary completion10 Apr 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies 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
- Model description
- A single center, interventional, parallel, double-blind (patient - and outcome-assessor), prospective, trial in patients scheduled for elective cardiac procedures using CPB. The RCT will be conducted according to Good Clinical Practice (GCP) Guidelines and comply with the principles of the Declaration of Helsinki. The RCT will be registered in a public registry, and the study protocol with its statistical analysis plan will be published before enrolment of the first patient.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed R El Tahan, MD, Study chair, College of Medicine, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312971
- Sponsor's protocol ID
- Norcal-03-2020
- Acronym
- Norcal
- Status last verified
- Dec 2021
- First submitted
- 15 Mar 2020
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The database will be locked as soon as all data are entered, and all discrepant or missing data are resolved - or if all efforts are employed and the investigators consider that the remaining issues cannot be fixed. At this step, the data will be reviewed before database locking. After that, the study database will be locked and exported for statistical analysis.
Publications
Tsiouris A, Wilson L, Haddadin AS, Yun JJ, Mangi AA. Risk assessment and outcomes of vasoplegia after cardiac surgery. Gen Thorac Cardiovasc Surg. 2017 Oct;65(10):557-565. doi: 10.1007/s11748-017-0789-6. Epub 2017 Jun 13.
PubMed 28612323Fischer 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 21092891Shaefi S, Mittel A, Klick J, Evans A, Ivascu NS, Gutsche J, Augoustides JGT. Vasoplegia After Cardiovascular Procedures-Pathophysiology and Targeted Therapy. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):1013-1022. doi: 10.1053/j.jvca.2017.10.032. Epub 2017 Oct 27.
PubMed 29223724Truby LK, Takeda K, Farr M, Beck J, Yuzefpolskaya M, Colombo PC, Topkara VK, Mancini D, Naka Y, Takayama H. Incidence and Impact of On-Cardiopulmonary Bypass Vasoplegia During Heart Transplantation. ASAIO J. 2018 Jan/Feb;64(1):43-51. doi: 10.1097/MAT.0000000000000623.
PubMed 28777136Chan JL, Kobashigawa JA, Aintablian TL, Li Y, Perry PA, Patel JK, Kittleson MM, Czer LS, Zarrini P, Velleca A, Rush J, Arabia FA, Trento A, Esmailian F. Vasoplegia after heart transplantation: outcomes at 1 year. Interact Cardiovasc Thorac Surg. 2017 Aug 1;25(2):212-217. doi: 10.1093/icvts/ivx081.
PubMed 28459983Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.
PubMed 29889106Cotter EK, Kidd B, Flynn BC. Elevation of Intraoperative Lactate Levels During Cardiac Surgery: Is There Power in This Prognostication? J Cardiothorac Vasc Anesth. 2020 Apr;34(4):885-887. doi: 10.1053/j.jvca.2019.11.049. Epub 2019 Dec 9. No abstract available.
PubMed 31899137Ortoleva J, Shapeton A, Vanneman M, Dalia AA. Vasoplegia During Cardiopulmonary Bypass: Current Literature and Rescue Therapy Options. J Cardiothorac Vasc Anesth. 2020 Oct;34(10):2766-2775. doi: 10.1053/j.jvca.2019.12.013. Epub 2019 Dec 14.
PubMed 31917073
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Norepinephrine Infusion During Cardiopulmonary Bypass on Perioperative Changes in Lactic Acid Level: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04312971
- Acronym / sponsor ID
- Norcal / Norcal-03-2020
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 18 Mar 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.
The primary objective is to test the efficacy and safety of the accuracy of continuous intravenous infusion of norepinephrine during cardiopulmonary bypass (CPB) on the prevention of hyperlactatemia after cardiac surgery.
"Efficacy" would be tested with measurement of the postoperative changes in lactic acid level over time from the baseline value before induction of general anesthesia.
"safety" would be tested with observing the post-cardiotomy need for inotropic and vasopressor support, the incidence of postoperative acute kidney injury (AKI), changes in cardiac troponin level (CnTnI), and signs of ischemic splanchnic injury.
Detailed description
Rationale
1.1. Vasoplegia and cardiac surgery:
Vasoplegia Syndrome (VS), prevailing in about 20% of cardiac surgical procedures (1), is defined as low mean arterial pressure (MAP) with normal or high cardiac indices and which is resistant to treatment with the commonly used vasopressors. (2,3) Vasoplegia might occur either during or after the cardiopulmonary bypass periods or during the postoperative period during the intensive care unit (ICU) stay. (3) Many factors have been found to be related to the increased Vasoplegia during the cardiopulmonary bypass period such as left ventricular ejection fraction more than 40%, male patients, elderly patients, higher body mass index, long cardiopulmonary bypass time, hypotension upon the start of cardiopulmonary bypass, perioperative use of angiotensin-converting enzyme inhibitors (ACE) and presence of infective endocarditis. (4,5)
1.2. Effects of Cardiopulmonary bypass (CPB) on Post cardiotomy Vasoplegia.
Cardiopulmonary bypass itself may intensify the effects of vasoplegia due to hemodilution which decreases the blood viscosity, so, reducing the overall peripheral vascular resistance. Moreover, the interaction of blood with the tubing of the cardiopulmonary bypass machine results in the release of inflammatory mediators which play an important role in reducing the peripheral resistance and aggravating the hypotension. Although compensatory and auto-regulatory mechanisms play an important role in maintaining adequate tissue perfusion, hypotension during the cardiopulmonary bypass period may result in poor outcomes as postoperative stroke (4) especially if the mean arterial pressure is below 65 mmHg. (6)
1.3. Hyperlactatemia after cardiac surgery
Lactate was used as a marker for adequate tissue perfusion since the mid-1800s. Although the literature has illustrated the undesirable effects of high lactate levels, however, the cause, the prevention as well as treatment measures of hyperlactatemia remain obscure. Additionally, lactic acidosis or hyperlactatemia might occur in cases of refractory vasoplegia. A rise in lactate levels is common during cardiac surgery and is well known for its deleterious and its association with poor patients' outcomes. (7)
Owing to its detrimental effects, measures to reduce the effects and treat vasoplegia were used. Firstly, excluding any equipment or mechanical failure such as the arterial line monitor, adjusting the bypass flows for higher cardiac index (CI>2.2), confirming the proper cannula position and ruling out any aortic dissection.
Secondly, adjusting some physiological parameters is of great value as checking hematocrit level for excessive hemodilution, adjusting the anesthetics with severe vasodilatory properties, excluding the possibility of a drug reaction or anaphylaxis and temperature management during hypothermic bypass.
Thirdly, the use of conventional vasopressor agents as phenylephrine, norepinephrine, and vasopressin. Finally, the use of some off-label agents as vitamin C, hydroxocobalamin, angiotensin 2, methylene blue and prostaglandin inhibitors. (8)
1.4. Why this clinical trial?
The use of norepinephrine during CPB has its own potential benefits. It is not clear if the use of continuous norepinephrine infusion during CPB would be effective and safe in lessening the postoperative hyperlactatemia and development of vasoplegia after cardiac surgery.
The here proposed randomized controlled clinical trial will test the use of continuous norepinephrine infusion during CPB with respect to the efficacy and safety to reduce the postoperative rise in blood lactate level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A single center, interventional, parallel, double-blind (patient - and outcome-assessor), prospective, trial in patients scheduled for elective cardiac procedures using CPB. The RCT will be conducted according to Good Clinical Practice (GCP) Guidelines and comply with the principles of the Declaration of Helsinki. The RCT will be registered in a public registry, and the study protocol with its statistical analysis plan will be published before enrolment of the first patient.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Other: Increase infusion rate, Other: Decrease infusion rateInfusion of normal Saline 0.9%will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time. |
| Norepinephrine | Active comparator | Drug: Norepinephrine, Other: Increase infusion rate, Other: Decrease infusion rateInfusion of norepinephrine (40 µg/ml) will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status between ІІІ and ІV
- Scheduled for any type of elective cardiac surgery using CPB
- General anesthesia provided in an endotracheally intubated patient.
Key exclusion criteria (12 listed)
- Decline consent to participate.
- Emergency surgery.
- Ejection fraction (EF%) less than 35%.
- Scheduled for re-do surgery.
- Scheduled for emergency surgery.
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 |
|---|---|---|
| PlaceboPatients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of Normal Saline 0.9% with a starting dose of 0.0025 ml/kg/min. | Drug | Placebo |
| NorepinephrinePatients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of norepinephrine (40 ug/ml) with a starting dose of 0.0025 ml/kg/min. | Drug | Norepinephrine |
| Increase infusion rateInfusion rate will be increased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min increments | Other | Norepinephrine, Placebo |
| Decrease infusion rateInfusion rate will be decreased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min decrements | Other | Norepinephrine, Placebo |
Primary outcome
Changes in lactic acid level
Time frame: For 24 hours after surgery from the start of surgery
perioperative changes in lactic acid level measured from arterial or venous blood
43 secondary outcomes
Mean Arterial Pressure (MAP)
Time frame: For 24 hours after surgery from the start of surgery
Cardiac Index (CI)
Time frame: For 24 hours after surgery from the start of surgery
Systemic Vascular Resistance index (SVRI)
Time frame: For 24 hours after surgery from the start of surgery
Stroke volume variation (SVV)
Time frame: For 24 hours after surgery from the start of surgery
Need for rescue doses of phenylephrine
Time frame: For the time of surgery
Need for rescue doses of norepinephrine
Time frame: For the time of surgery
Need for rescue doses of ephedrine
Time frame: For the time of surgery
Need for rescue doses of nitroglycerine
Time frame: For the time of surgery
Need for rescue doses of labetalol
Time frame: For the time of surgery
Need for rescue doses of esmolol
Time frame: For the time of surgery
Need for rescue doses of atropine
Time frame: For the time of surgery
Need for rescue doses of glycopyrrolate.
Time frame: For the time of surgery
Intraoperative hypoxemia
Time frame: For the time of surgery
Intraoperative hypercapnia
Time frame: For the time of surgery
Intraoperative hypotension
Time frame: For the time of surgery
Intraoperative bradycardia
Time frame: For the time of surgery
Intraoperative myocardial ischemic episodes
Time frame: For the time of surgery
Number of patients who required pacemaker insertion
Time frame: For the time of surgery
Number of patients who required direct current shocks
Time frame: For the time of surgery
Number of patients who need for epinephrine
Time frame: For the time of surgery
Number of patients who need for norepinephrine
Time frame: For the time of surgery
Number of patients who need for dobutamine
Time frame: For the time of surgery
Number of patients who need for milrinone
Time frame: For the time of surgery
Number of patients who need for for Intra-Aortic Balloon Pump
Time frame: For the time of surgery
Intraoperative need for blood transfusion
Time frame: For the time of surgery
Intraoperative fluid intake
Time frame: For the time of surgery
ICU Stay
Time frame: For 30 days after surgery
Hospital Stay
Time frame: For 30 days after surgery
Mortality at 30 days
Time frame: For 30 days after surgery
Mortality at 90 days
Time frame: For 90 days after surgery
Postoperative need for reintubation
Time frame: For 30 days after surgery
Postoperative bleeding
Time frame: For 30 days after surgery
Postoperative cardiogenic shock
Time frame: For 30 days after surgery
Postoperative acute kidney injury
Time frame: For 30 days after surgery
Postoperative splanchnic ischemia
Time frame: For 30 days after surgery
Postoperative myocardial ischemia
Time frame: For 30 days after surgery
Postoperative wound infection
Time frame: For 30 days after surgery
Postoperative pneumonia
Time frame: For 30 days after surgery
Postoperative mediastinitis
Time frame: For 30 days after surgery
Postoperative hypoxemia
Time frame: For 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Background: PubMed 28612323Tsiouris A, Wilson L, Haddadin AS, Yun JJ, Mangi AA. Risk assessment and outcomes of vasoplegia after cardiac surgery. Gen Thorac Cardiovasc Surg. 2017 Oct;65(10):557-565. doi: 10.1007/s11748-017-0789-6. Epub 2017 Jun 13.
- 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 29223724Shaefi S, Mittel A, Klick J, Evans A, Ivascu NS, Gutsche J, Augoustides JGT. Vasoplegia After Cardiovascular Procedures-Pathophysiology and Targeted Therapy. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):1013-1022. doi: 10.1053/j.jvca.2017.10.032. Epub 2017 Oct 27.
- Background: PubMed 28777136Truby LK, Takeda K, Farr M, Beck J, Yuzefpolskaya M, Colombo PC, Topkara VK, Mancini D, Naka Y, Takayama H. Incidence and Impact of On-Cardiopulmonary Bypass Vasoplegia During Heart Transplantation. ASAIO J. 2018 Jan/Feb;64(1):43-51. doi: 10.1097/MAT.0000000000000623.
- Background: PubMed 28459983Chan JL, Kobashigawa JA, Aintablian TL, Li Y, Perry PA, Patel JK, Kittleson MM, Czer LS, Zarrini P, Velleca A, Rush J, Arabia FA, Trento A, Esmailian F. Vasoplegia after heart transplantation: outcomes at 1 year. Interact Cardiovasc Thorac Surg. 2017 Aug 1;25(2):212-217. doi: 10.1093/icvts/ivx081.
- Background: PubMed 29889106Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.
- Background: PubMed 31899137Cotter EK, Kidd B, Flynn BC. Elevation of Intraoperative Lactate Levels During Cardiac Surgery: Is There Power in This Prognostication? J Cardiothorac Vasc Anesth. 2020 Apr;34(4):885-887. doi: 10.1053/j.jvca.2019.11.049. Epub 2019 Dec 9. No abstract available.
- Background: PubMed 31917073Ortoleva J, Shapeton A, Vanneman M, Dalia AA. Vasoplegia During Cardiopulmonary Bypass: Current Literature and Rescue Therapy Options. J Cardiothorac Vasc Anesth. 2020 Oct;34(10):2766-2775. doi: 10.1053/j.jvca.2019.12.013. Epub 2019 Dec 14.
- Individual participant dataSharing planned: Yes. The database will be locked as soon as all data are entered, and all discrepant or missing data are resolved - or if all efforts are employed and the investigators consider that the remaining issues cannot be fixed. At this step, the data will be reviewed before database locking. After that, the study database will be locked and exported for statistical analysis.
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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 R El Tahan, MD study chair
College of Medicine, Imam Abdulrahman Bin Faisal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine, Increase infusion rate and Decrease infusion rate in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in lactic acid level (time frame: For 24 hours after surgery from the start of surgery). 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 NCT04312971, which also lists 8 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 10 Dec 2021.