An Intervention to Reduce Delirium After Cardiac Surgery

NCT02587039 | Completed

• 1 other identifier: IRB00030360
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Patients that have cardiac surgery may suffer from unrecognized cerebral ischemia or loss of blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the brain may result in a condition called delirium. Delirium is a type temporary confusion. There are some strategies that can help reduce cerebral ischemia during cardiac surgery which can help lead to a reduction in the incidence of delirium. The investigator believes that a strategy called remote ischemic preconditioning will help to reduce the incidence of delirium incidence after cardiac surgery. Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to ischemia occurs in an area of the body that is not undergoing a procedure. This brief exposure to ischemia is not long enough to cause any damage to the body and it has been demonstrated to help protect against more severe ischemic injury that may occur later during surgery. In this study the investigator will use remote ischemic preconditioning to see if it can reduce the incidence delirium after cardiac surgery.

Conditions

Delirium; Congenital Heart Disease; Coronary Artery Disease; Heart Valve Disease

Keywords

delirium; heart; valve; graft; surgery; coronary

Outcome Measures

Primary Outcomes (1)

• Incident Delirium

  Delirium will be assessed using the Confusion Assessment Method (CAM) on three of the first four postoperative days. The primary outcome will be positive if delirium occurs by CAM criteria at any of these assessments

  First four postoperative days

Secondary Outcomes (1)

• Levels of novel cerebral injury biomarkers

  Within 1 hour before the surgical incision, immediately after cardiopulmonary bypass, 2 hours after cardiopulmonary bypass, and 20 hours after skin closure

Other Outcomes (1)

• Instrumental Activities of Daily Living

  1 month and 6 months after surgery

Study Arms (2)

Control: Usual care

PLACEBO COMPARATOR

This group will receive usual care and delirium assessments.

Behavioral: Delirium Assessment

Treatment: Ischemic Pre-conditioning

EXPERIMENTAL

Remote Ischemic pre-conditioning before cardiac surgery and delirium assessments.

Procedure: Remote ischemic pre-conditioning; Behavioral: Delirium Assessment

Interventions

Remote ischemic pre-conditioning PROCEDURE

Remote ischemic preconditioning is exposure to a brief period ischemia to an area or limb that is not involved in surgery. This intervention is believed to reduce the incidence of cerebral (brain) ischemia during cardiac surgery.

Treatment: Ischemic Pre-conditioning

Delirium Assessment BEHAVIORAL

The Delirium assessment consist of a validated psychiatric screening tool called the Confusion Assessment Method. We will use this tool to determine if patients have any confusion after surgery.

Control: Usual care; Treatment: Ischemic Pre-conditioning

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥65 years old
• Undergoing coronary artery bypass and/or valve surgery

You may not qualify if:

• Mini mental state exam \< 23
• Delirium at baseline
• Inability to speak and understand English
• Severe hearing impairment, resulting in inability to converse
• Planned use of intraoperative ketamine
• Inability to place or tolerate upper extremity tourniquet
• Hemoglobinopathy (e.g. sickle cell disease)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Nakano M, Nomura Y, Suffredini G, Bush B, Tian J, Yamaguchi A, Walston J, Hasan R, Mandal K, Schena S, Hogue CW, Brown CH 4th. Functional Outcomes of Frail Patients After Cardiac Surgery: An Observational Study. Anesth Analg. 2020 Jun;130(6):1534-1544. doi: 10.1213/ANE.0000000000004786.

  PMID: 32384343 DERIVED

• Nomura Y, Nakano M, Bush B, Tian J, Yamaguchi A, Walston J, Hasan R, Zehr K, Mandal K, LaFlam A, Neufeld KJ, Kamath V, Hogue CW, Brown CH 4th. Observational Study Examining the Association of Baseline Frailty and Postcardiac Surgery Delirium and Cognitive Change. Anesth Analg. 2019 Aug;129(2):507-514. doi: 10.1213/ANE.0000000000003967.

  PMID: 30540612 DERIVED

MeSH Terms

Conditions

Delirium; Heart Defects, Congenital; Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Charles Brown, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: October 27, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

US (1)