Email updates

Keep up to date with the latest news and content from Trials and BioMed Central.

Open Access Study protocol

The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

Mark Coburn1*, Robert D Sanders2, Mervyn Maze3, Rolf Rossaint1 and on behalf of the HIPELD Investigators

Author Affiliations

1 Department of Anaesthesiology, University Hospital Aachen, RWTH, Aachen, Germany

2 Department of Anaesthetics, Intensive Care and Pain Medicine, Imperial College London, London, UK

3 Department of Anaesthesia and Perioperative Care, University of California, San Francisco, USA

For all author emails, please log on.

Trials 2012, 13:180  doi:10.1186/1745-6215-13-180

Published: 27 September 2012

Abstract

Background

Strategies to protect the brain from postoperative delirium (POD) after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i) by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABA)A receptor and (ii) through beneficial anesthetic and organ-protective effects.

Methods and design

An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM), in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome) is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years) and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane).

Trial registration

EudraCT Identifier: 2009-017153-35; ClinicalTrials.gov Identifier: NCT01199276

Keywords:
Hip fracture; Postoperative delirium; Xenon