Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery

PeriOperative Interventional Neuroprotection Trial (POINT)

Sponsoren

Hauptsponsor: Duke University

Mitarbeiter: National Heart, Lung, and Blood Institute (NHLBI)

Quelle Duke University
Kurze Zusammenfassung

The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery.

detaillierte Beschreibung

BACKGROUND:

Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery.

DESIGN NARRATIVE:

This study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.

Gesamtstatus Completed
Anfangsdatum December 2001
Fertigstellungstermin May 2009
Primäres Abschlussdatum May 2009
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Cognitive Function Measured at baseline and 6 weeks
Einschreibung 389
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Magnesium

Beschreibung: 100 mg/kg

Armgruppenetikett: Magnesium

Interventionsart: Drug

Interventionsname: 0.9% saline

Beschreibung: Placebo

Armgruppenetikett: 0.9 % saline

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Coronary heart disease

Exclusion Criteria:

- Early dementia

- History of psychiatric illness

Geschlecht: All

Mindestalter: 55 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Mark F. Newman, MD Study Chair Duke University
Ort
Einrichtung: Duke University Medical Center
Standort Länder

United States

Überprüfungsdatum

April 2012

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Magnesium

Art: Active Comparator

Beschreibung: 100 mg/kg magnesium

Etikette: 0.9 % saline

Art: Placebo Comparator

Beschreibung: 100 mg/kg 0.9 % saline

Akronym POINT
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Triple (Participant, Care Provider, Investigator)

Quelle: ClinicalTrials.gov