The effect on cerebral oxygenation of retrograde autologous priming of the CPB circuit in cardiac surgery patients: a Randomized Controlled Trial

The effect on cerebral oxygenation of retrograde autologous priming of the CPB circuit in cardiac surgery patients: a Randomized Controlled Trial - The effect on cerebral oxygenation of RAP of the CPB circuit

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38712

Enrollment

220

Registered

2013-12-12

Start date

2014-12-08

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

cognition regional cerebral oxygenation

Interventions

The subjects who are divided in the RAP group, the retrograde autologous priming technique will be used, where the patient*s own circulating blood partially will be replaced by the priming solution

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Gender; male/ female • Age: >= 70 year • Elective cardiac surgical patients who underwent combined procedure o Coronary artery bypass graft (CABG) surgery combined with valve surgery: o CABG/ Aortic valve replacement (AVR) o CABG/ Mitral valve replacement (MVR) o CABG/ Mitral valve repair (MPL) o CABG/ Tricuspid valve replacement (TVR) o CABG/ Tricuspid valve repair (TPL)

Exclusion criteria

Exclusion criteria: • Elective cardiac surgical patients who underwent single procedure o Coronary artery bypass graft (CABG) (conventional, E.CCO) o Aortic valve replacement (AVR) (conventional, minimal invasive) o Bentall o Combined procedure (eg. MVR/AVR, AVR/Maze) o Tricuspid valve replacement (TVR) / Tricuspid valve repair (TPL) o MVR/MPL (conventional, minimal invasive, Port Access Surgery) o Maze (minimal invasive, via Thoracoscopy) o off-pump procedures o re-operation o Other • Emergency operations • Methylene blue administration

Design outcomes

Primary

Measure	Time frame
The primary study parameter of this study is prolonged intraoperative cerebral desaturation and will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 > 3000 is associated with increased risk of cognitive decline (1). Formula described by Slater et al. : rSO2 score = 50% rSO2 - current rSO2 (%) x time (s) will be used to calculate the rSO2 score; from the intraoperative cerebral oximetry data (1).	—

Measure

Time frame

The primary study parameter of this study is prolonged intraoperative cerebral desaturation and will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 > 3000 is associated with increased risk of cognitive decline (1). Formula described by Slater et al. : rSO2 score = 50% rSO2 - current rSO2 (%) x time (s) will be used to calculate the rSO2 score; from the intraoperative cerebral oximetry data (1).

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Secondary

Measure	Time frame
List of secondary study parameters: • CODE (number and duration) • rSO2 during CPB • Subjective Cognition Failure Questionnaire (one day preoperatively, 3 months after randomization, 6 months after randomization) • Hct/ Hb during CPB o Nadir Hb, Hct intraoperative, during postoperative ICU & hospital stay • Surgical re-explorations • Length of ICU stay • Length of hospital stay • Hours to detubation • Neurological events • Fluid balance • Administration of vasoactive drugs during CPB • sVO2 during CPB	—

Measure

Time frame

List of secondary study parameters: • CODE (number and duration) • rSO2 during CPB • Subjective Cognition Failure Questionnaire (one day preoperatively, 3 months after randomization, 6 months after randomization) • Hct/ Hb during CPB o Nadir Hb, Hct intraoperative, during postoperative ICU & hospital stay • Surgical re-explorations • Length of ICU stay • Length of hospital stay • Hours to detubation • Neurological events • Fluid balance • Administration of vasoactive drugs during CPB • sVO2 during CPB

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)