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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

Massoudy 1999.

Study characteristics
Methods Prospective, randomised, double‐blind study
Run‐in period: not specified. Approved by ethics committee August 1996. Accepted for publication October 14, 1998
Number of centres and location: not specified. Authors from the German Heart Center Munich, and the Department of Physiology, University of Munich, Munich, Germany
Participants Twenty‐two patients undergoing elective CABG. Inclusion criteria were the following:

  1. LVEF ≤ 55%;

  2. age ≤ 75 years ; and

  3. no MI (as defined by significant elevation of serum CK levels or electrocardiographic signs for MI) within 14 days before the operation.


Exclusion criteria were known hypersensitivity against SNP or any other nitro substances, inflammatory diseases, or the intake of immunosuppressive drugs.
Interventions Intervention: sodium nitroprusside (Nipruss 0.5 μg/kg/min after release of the aortic cross‐clamp for 20 minutes through the central venous line of a Swan‐Ganz catheter)
Control: 5% glucose solution
Protamine (1 mg/kg) was given after CPB in both groups.
Outcomes ILs and mortality
Notes No clinical outcomes reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No clear description regarding randomisation technique
Allocation concealment (selection bias) Unclear risk No clear description of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No description of blinding procedures
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No description of blinding procedures for outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants completed the trial and were included in the final analysis.
Selective reporting (reporting bias) Low risk All prespecified variables were reported.
Other bias Low risk The sodium nitroprusside was donated by a pharmaceutical company who was not otherwise involved in the study. Thus, we rate this at low risk of funding bias.