N/A N=80 Randomized Double-blind Treatment

Nitroglycerin Infusion During Cardiac Surgery

Lactic Acidosis · Blood Glucose, High

Bottom Line

View on ClinicalTrials.gov: NCT01901419 ↗

Enrolled (actual)

Serious AEs

6.4%

Results posted

Nov 2020

Primary outcome: Primary: Plasma Lactate Level, Before Incision — 1.1; 1.0 mmol/L — p=0.618

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nitroglycerin infusion (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Tri-Service General Hospital
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Lactate Level, Before Incision	1.1; 1.0	0.618
PRIMARY Plasma Lactate Level, Before Start of CPB	1.4; 1.6	0.410
PRIMARY Plasma Lactate Level, Release of Aortic Clamp	3.1; 2.6	0.088
PRIMARY Plasma Lactate Level, After Protamine Administration	3.3; 3.0	0.320
PRIMARY Plasma Lactate Level, Upon Arrival at ICU	3.4; 3.2	0.512
PRIMARY Plasma Glucose Level, Before Incision	139.4; 124.2	0.144
PRIMARY Plasma Glucose Level, Before Start of CPB	179.2; 165.7	0.338
PRIMARY Plasma Glucose Level, Release of Aortic Clamp	174.5; 165.0	0.356
PRIMARY Plasma Glucose Level, After Protamine Administration	196.9; 205.7	0.478
PRIMARY Plasma Glucose Level, Upon Arrival at ICU	206.4; 214.8	0.515
PRIMARY Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion	6; 0	<0.001 sig
SECONDARY Activated Coagulation Time, Before Start of CPB	158.9; 153.1	0.227
SECONDARY Activated Coagulation Time, After Protamine Administration	144.2; 138.2	0.141
SECONDARY Post-op Dopamine Infusion	3.7; 4.7	0.046 sig
SECONDARY Time to Extubation	43.6; 45.8	0.800
SECONDARY Length of ICU Stay	4.1; 4.0	0.948

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.

Eligibility Criteria

Inclusion Criteria

elective cardiac surgery

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01901419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.