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The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient (TAUP)
This study is currently recruiting participants.
Verified by Medical Center Alkmaar, July 2007
First Received: July 6, 2007   No Changes Posted
Sponsored by: Medical Center Alkmaar
Information provided by: Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT00497978
  Purpose

The purpose of this study is to reduce the postoperative morbidity and mortality in the elderly hip fracture patient, by giving them taurine peri-operatively.


Condition Intervention
Insulin Resistance
Elderly Patient
Oxidative Stress
Drug: taurine

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement
Drug Information available for: Taurine
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient

Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:
  • morbidity and mortality [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • - antioxidant/oxidant parameters and inflammatory mediators - postoperative insulin resistance - mitochondrial dysfunction in the skeletal muscle - postoperative delirium incidence, duration and severity [ Time Frame: 1 week ]

Estimated Enrollment: 236
Study Start Date: July 2007
Estimated Study Completion Date: July 2010
Detailed Description:

Rationale: A growing medical concern is the increase in the number of very old patients, especially the patients undergoing hip fracture surgery are rapidly increasing in numbers. Hip surgery in these old patients induces serious morbidity and gives rise to excessive mortality rates. Studies with perioperative nutritional interventions performed within this population have shown improved clinical outcome, but were not well controlled and lack insight in the working mechanism. Therefore nutritional intervention studies are needed using a single nutrient. In trauma patients for instance it is known that the administration of glutamine (as a single amino acid) reduces morbidity, which is probably related to its antioxidant properties; reducing oxidative stress and insulin resistance. As an antioxidant the amino acid taurine has even greater potential providing benefit in several groups of patients. Elderly hip fracture patients have very low plasma levels of antioxidants which make them highly vulnerable for oxidative stress and related insulin resistance.In elderly patients with a hip fracture, it is hypothesized that taurine lowers oxidative stress and the related harmful insulin resistance, thereby reducing morbidity and mortality.

Objective: Our primary objective is to reduce morbidity and consequent mortality in the elderly hip fracture patient by the administration of taurine.

Study design: A double blind placebo controlled intervention study at the surgery department of the Medical Center Alkmaar. The study consists of three parts: 1. A dose finding study; 2. Main study: outcome study on morbidity and mortality; 3. A study on insulin resistance, parallel to the main study.

Study population: Patients of both genders and any ethnicity, who will undergo primary surgery for a hip fracture, aged over 75 years, will be eligible for the study.

Intervention: Patients will receive from the moment of admission oral administration of taurine (3g/day or 6g/day, depending on results of the dose finding study) or placebo.

Main study parameters/endpoints: The main study parameter is the morbidity and consequent mortality. The secondary study parameters are oxidative stress, postoperative insulin resistance, mitochondrial dysfunction in skeletal muscle and postoperative delirium.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The possible benefit of the study is related to the effect of taurine. Oral administration of taurine, as an antioxidant, perioperatively, can reduce morbidity and consequent mortality, reduce oxidative stress, counteract the postoperative insulin resistance and thereby enhance the clinical outcome of the elderly hip fracture patient. Research showed that taurine can be safely administered to humans and no adverse effects are reported. A part of the patients will undergo a hyperinsulinaemic euglycaemic clamp to assess hepatic and peripheral insulin sensitivity.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age above 75 years old
  • hip fracture with a primary indication for surgery
  • having obtained his/her informed consent

Exclusion Criteria:

  • participating in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497978

Contacts
Contact: Alexander PJ Houdijk, MD, PhD 0031 72 5484444 ext 5383 a.p.j.houdijk@mca.nl

Locations
Netherlands, Noord-Holland
Medical Center Alkmaar Recruiting
Alkmaar, Noord-Holland, Netherlands, 1800 AM
Contact: Alexander PJ Houdijk, MD, PhD     0031 72 5484444 ext 5383     a.p.j.houdijk@mca.nl    
Principal Investigator: Alexander PJ Houdijk, MD, PhD            
Sub-Investigator: Mireille FM van Stijn, MD            
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Principal Investigator: Alexander PJ Houdijk, MD, PhD Medical Center Alkmaar
  More Information

No publications provided

Study ID Numbers: TAUP03.04.07/2
Study First Received: July 6, 2007
Last Updated: July 6, 2007
ClinicalTrials.gov Identifier: NCT00497978     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:
Hyperinsulinism
Hip Fractures
Femoral Fractures
Metabolic Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Stress
Leg Injuries
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Hyperinsulinism
Hip Fractures
Femoral Fractures
Metabolic Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Hip Injuries
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009