Phase 3 Completed N=25 Randomized Triple-blind Supportive Care

Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

Postoperative cognitive dysfunction

Source: ClinicalTrials.gov NCT01149148 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Aug 2012

Primary outcomePrimary: Mini Mental State Examination (MMSE) — 27; 26.769 scores on a scale — p=0.678

Summary

The investigators hypothesize that early intervention to optimize regional cerebral oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient and permanent neurological dysfunction and improve neurocognitive impairment.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mini Mental State Examination (MMSE)	27.667; 27	—

Eligibility Criteria

Inclusion Criteria

Adult male and female patients 18-80 years of age scheduled for aortic surgery requiring DHCA and intention to use antegrade selective cerebral perfusion with or without RCP

Exclusion Criteria

Adult male and female patients 18-80 years of age undergoing aortic surgery NOT scheduled for DHCA
Patients with ejection fraction < 15%
Pregnancy
Prisoners
Patients mentally impaired (Screening Criteria i.e. MMSE score ≤ 23) History of stroke

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01149148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.