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The “Blood pressure and oxygenation targets in post resuscitation care, a randomized clinical trial”: design and statistical analysis plan

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Background: Comatose patients admitted after resuscitation from cardiac arrest have a significant risk of poor outcome due to hypoxic brain injury. While numerous studies have investigated and challenged the target temperature as the efficacious part of the guideline endorsed Targeted Temperature Management (TTM) protocols, our knowledge and how the remaining parts of the TTM are optimized remain sparse. The present randomized trial investigated two aspects of the TTM protocol: target blood pressure during the ICU stay and oxygenation during mechanical ventilation. Furthermore, the efficacy of device-based post-TTM fever management is addressed. Methods: Investigator-initiated, dual-center, randomized clinical trial in comatose OHCA patients admitted to an intensive cardiac care unit. Patients are eligible for inclusion if unconscious, older than 18 years of age, and have return of spontaneous circulation for more than 20 min. Intervention: allocation 1:1:1:1 into a group defined by (a) blood pressure targets in double-blind intervention targeting a mean arterial blood pressure of 63 or 77 mmHg and (b) restrictive (9–10 kPa) or liberal (13–14 kPa) of arterial oxygen concentration during mechanical ventilation. As a subordinate intervention, device-based active fever management is discontinued after 36 h or 72. Patients will otherwise receive protocolized standard of care according to international guidelines, including targeted temperature management at 36 °C for 24 h, sedation with fentanyl and propofol, and multimodal neuro-prognostication. Primary endpoint: Discharge from hospital in poor neurological status (Cerebral Performance category 3 or 4) or death, whichever comes first. Secondary outcomes: Time to initiation of renal replacement therapy or death, neuron-specific enolase (NSE) level at 48 h, MOCA score at day 90, Modified Ranking Scale (mRS) and CPC at 3 months, NT-pro-BNP at 90 days, eGFR and LVEF at 90 days, daily cumulated vasopressor requirement during ICU stay, and need for a combination of vasopressors and inotropic agents or mechanical circulatory support. Discussion: We hypothesize that low or high target blood pressure and restrictive and liberal oxygen administration will have an impact on mortality by reducing the risk and degree of hypoxic brain injury. This will be assessment neurological outcome and biochemical and neuropsychological testing after 90 days. Trial registration: NCT03141099. Registered on May 2017 (retrospectively registered)

Udgave nummer1
StatusUdgivet - dec. 2022

Bibliografisk note

Funding Information:
Jesper Kjaergaard: Sponsor-investigator, developed the blinding method of the blood pressure intervention, responsible for the conduct of the trial and data collection, drafted the original protocol, and applied for approvals from regulating authorities. Responsible for the primary publication manuscript of the blood pressure intervention. Henrik Schmidt: Site investigator, co-drafted the protocol, responsible for the data integrity of the Odense site. Jacob E Møller: Co-investigator, co-drafted the protocol, responsible for the primary publication manuscript of the liberal vs. restrictive oxygenation strategy. Christian Hassager: Site investigator, co-drafted the original protocol, responsible for the primary publication manuscript of the duration of active temperature management strategy. All authors read and approved the final manuscript. NovoNordisk Foundation: NNF17OC0028706. DKK 7,573,000 for the full trial budget. The funding body had and will have no role in the design of the study and collection, analysis, and interpretation of data. On request and based on approval from relevant authorities, any data required to support the protocol can be supplied.

Publisher Copyright:
© 2022, The Author(s).

ID: 79409603