Nitroglycerin Infusion During Cardiac Surgery

NCT01901419 | Completed Results DMC

• 1 other identifier: TSGHIRB 1-102-05-049
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic inflammatory response, while insufficient and delayed neutralization of heparin by protamine may contribute to more blood loss during rewarming stage. Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment for unstable angina, myocardial infarction, congestive heart failure, and perioperative hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin infusion during rewarming corrects systemic ischemic stress and facilitates heparin neutralization in cardiac surgery.

Conditions

Lactic Acidosis; Blood Glucose, High

Keywords

nitroglycerin; cardiopulmonary bypass; cardiac surgery

Outcome Measures

Primary Outcomes (11)

• Plasma Lactate Level, Before Incision

  Plasma Lactate Level, mmol/L, Before Incision

  Before Incision

• Plasma Lactate Level, Before Start of CPB

  Plasma Lactate Level, mmol/L, Before Start of CPB

  Before Start of CPB

• Plasma Lactate Level, Release of Aortic Clamp

  Plasma Lactate Level, mmol/L, Release of Aortic Clamp

  Release of Aortic Clamp

• Plasma Lactate Level, After Protamine Administration

  Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration

  After Protamine Administration

• Plasma Lactate Level, Upon Arrival at ICU

  Plasma Lactate Level, mmol/L, Upon Arrival at ICU

  Upon Arrival at ICU

• Plasma Glucose Level, Before Incision

  Plasma Glucose Level, mg/dL, Before Incision

  Before Incision

• Plasma Glucose Level, Before Start of CPB

  Plasma Glucose Level, mg/dL, Before Start of CPB

  Before Start of CPB

• Plasma Glucose Level, Release of Aortic Clamp

  Plasma Glucose Level, mg/dL, Release of Aortic Clamp

  Release of Aortic Clamp

• Plasma Glucose Level, After Protamine Administration

  Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration

  After Protamine Administration

• Plasma Glucose Level, Upon Arrival at ICU

  Plasma Glucose Level, mg/dL, Upon Arrival at ICU

  Upon Arrival at ICU

• Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion

  Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass

  After Initiation of NTG infusion During Rewarming

Secondary Outcomes (5)

• Activated Coagulation Time, Before Start of CPB

  Before Start of CPB

• Activated Coagulation Time, After Protamine Administration

  After Protamine Administration

• Post-op Dopamine Infusion

  Upon Arrival at ICU

• Time to Extubation

  Arrival at ICU and Extubation

• Length of ICU Stay

  Arrival at ICU and Leaving ICU

Other Outcomes (14)

• Cardiac Index, Before Start of CPB

  Before Start of CPB

• Cardiac Index, Cessation of CPB

  Cessation of CPB

• Cardiac Index, After Protamine Administration

  After Protamine Administration

Study Arms (2)

High-dose NTG

EXPERIMENTAL

Nitroglycerin infusion 1-5 mcg/kg/min

Drug: Nitroglycerin infusion

Low-dose NTG

ACTIVE COMPARATOR

Nitroglycerin infusion 0-0.1 mcg/kg/min

Drug: Nitroglycerin infusion

Interventions

Nitroglycerin infusion DRUG

Nitroglycerin infusion during rewarming

Also known as: Millisrol

High-dose NTG; Low-dose NTG

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective cardiac surgery

You may not qualify if:

• heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Related Publications (2)

• Piquette D, Deschamps A, Belisle S, Pellerin M, Levesque S, Tardif JC, Denault AY. Effect of intravenous nitroglycerin on cerebral saturation in high-risk cardiac surgery. Can J Anaesth. 2007 Sep;54(9):718-27. doi: 10.1007/BF03026868.

  PMID: 17766739 BACKGROUND

• Masoumi G, Pour EH, Sadeghpour A, Ziayeefard M, Alavi M, Anbardan SJ, Shirani S. Effect of different dosages of nitroglycerin infusion on arterial blood gas tensions in patients undergoing on- pump coronary artery bypass graft surgery. J Res Med Sci. 2012 Feb;17(2):123-7.

  PMID: 23264783 BACKGROUND

MeSH Terms

Conditions

Acidosis, Lactic

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

One patient in NTG group experienced re-sternotomy to check bleeding in the same day and another one expired at the 25th day postoperatively due to mediastinitis with septic shock.

Results Point of Contact

• Title: Dr. Tso-Chou Lin
• Organization: Department of Anesthesiology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan

tclin@mail.ndmctsgh.edu.tw

+886-2-87927128

Study Officials

• Tso-Chou Lin, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 17, 2013
• Study Start: July 8, 2013
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after journal publication.
• Access Criteria: all IPD that underlie results in a publication are to be shared via email requests. The corresponding author will review requests and send them the supporting information.

Locations

TW (1)