Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study

Patrick Meybohm, Jochen Renner, Ole Broch, Dorothee Caliebe, Martin Albrecht, Jochen Cremer, Nils Haake, Jens Scholz, Kai Zacharowski, Berthold Bein, Patrick Meybohm, Jochen Renner, Ole Broch, Dorothee Caliebe, Martin Albrecht, Jochen Cremer, Nils Haake, Jens Scholz, Kai Zacharowski, Berthold Bein

Abstract

Background: Remote ischemic preconditioning (RIPC) has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD) in patients undergoing complex cardiac surgery.

Methods: We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5-7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion) or if the combined Z score was 1.96 or greater (Z score criterion).

Results: According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5-7 days after surgery (p = 0.753). The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30) compared to the RIPC group (1.14±4.02; p = 0.228). Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19-1.94) µg/L vs. 0.48 (0.07-1.84) µg/L] and 24 hours after surgery [0.36 (0.14-1.89) µg/L vs. 0.26 (0.07-0.90) µg/L].

Conclusions: We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed.

Trial registration: ClinicalTrials.gov NCT00877305.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. CONSORT flow diagram for individual…
Figure 1. CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment.
Patients scheduled for cardiac surgery with use of cardiopulmonary bypass were included. The day before surgery we checked for eligibility, obtained informed consent, assessed baseline variables, laboratory tests and baseline neurocognitive function. At the day of surgery, standardized general anesthesia and management of cardiopulmonary bypass was performed in all patients. RIPC and control were performed immediately prior to cardiopulmonary bypass. Neurocognitive dysfunction was assessed 5–7 days and 3 months after surgery.

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Source: PubMed

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