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Optimization Study of Cardiac Risk Patients With Hip Fracture

NCT01219712 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-10-13

No results posted yet for this study

Summary

Elderly patients undergoing surgery for proximal hip fracture have a high risk of morbidity and mortality (M\&M) postoperatively. Several studies including some from the investigators department have shown that there is a high risk of cardiovascular complications in this group of patients and 3-month mortality is 15-20%. One of the causes of this high M\&M is the high incidence of cardiac failure associated with an increased NT-proBNP in this group of patients. The aim of the present study is to evaluate whether optimization of preoperative cardiac function can reduce cardiac M\&M postoperatively. Following verbal consent, patients with an increased NT-proBNP would be randomized to goal-directed preoperative optimization or standard management according to current hospital routines. Following optimization, the patients would be transferred to the operating rooms and subsequent management including perioperative patient management would be left to the discretion of a specialist anesthesiologist who is directly involved in patient care. Postoperatively, Troponin T and NT-proBNP would be measured in all patients according to the study protocol. In addition, major adverse cardiac events would be documented and follow-up would be done by after 30 days and 3 months postoperatively.

Conditions

  • Left Ventricular Dysfunction
  • Femoral Fracture

Interventions

PROCEDURE

Colloids, dobutamin, levosimendan

: The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2. * Hb would be optimized to \> 90 g/l * SaO2 \> 96% * Stroke volume index (SVI) \> 30 * Heart rate should ideally be \< 80 Stroke volume index (SVI) \> 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is \< 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goal

Sponsors & Collaborators

  • Region Örebro County

    collaborator OTHER

  • Ryhov County Hospital

    collaborator OTHER

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Christina Eintrei, Professon · Department of Medical & Health Sciences Division of Drug Research/Anaesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-01-31
Completion
2013-02-28

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219712 on ClinicalTrials.gov