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Study of the control of oxygen levels during cardiopulmonary bypass - the SO-COOl study

Study of patients undergoing cardiopulmonary bypass to compare the effects of normoxia vs hyperoxia on organ function

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000756820
Acronym
The SO-COOL study
Enrollment
298
Registered
2012-07-16
Start date
2012-12-19
Completion date
2014-05-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Heart surgery is a common procedure, with more than 2500 operations each year in New Zealand. Damage to organs, including kidneys, liver and heart is common after heart surgery and some of the damage may be caused by extra oxygen given on cardiopulmonary bypass. This study will randomise patients to receive normal levels of oxygen or the traditional high levels during heart surgery. Endpoints include a number of blood tests that are very sensitive for detecting damage to the kidney, liver, heart and other organs. In total 286 patients having heart surgery at Auckland City Hospital will be included in this study over a two year period.

Interventions

During anaesthesia SpO2 will be kept at 92-95% and during CPB the oxygen tension of the arterial return blood flow will be kept at 10 - 12 kPa using continuous in-line real-time blood gas monitoring (Terumo CDI 500, Terumo Corporation).

Sponsors

Dr Shay McGuinness
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

Adult patient (over 16 yrs) Scheduled to have cardiac surgery using cardiopulmonary bypass Written informed consent obtained

Exclusion criteria

Preoperative acute renal failure within 6 weeks (acute rise in serum creatinine >50% from baseline) is present or Pre-operative end stage renal disease (serum creatinine >300 µmol/L) is present or receiving any form of renal replacement therapy or Pre-operative hepatic dysfunction (AST> 2* upper limit of normal) or Recent (< 6 weeks) cerebrovascular event, (Including CVA,TIA or intracerebral bleed) or Pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026