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The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient (TAUP)

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ClinicalTrials.gov Identifier: NCT00497978
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
Alexander P.J. Houdijk, Medical Center Alkmaar

Brief Summary:
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 or disease Intervention/treatment Phase
Insulin Resistance Elderly Patient Oxidative Stress Dietary Supplement: taurine Dietary Supplement: placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient
Study Start Date : March 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Taurine

Arm Intervention/treatment
Active Comparator: 1
taurine will be given per capsule
Dietary Supplement: taurine
6 grams of taurine will be given each day in capsules, starting the day of admission till the sixth postoperative day

Placebo Comparator: 2
placebo capsules containing microcrystalline cellulose will be given
Dietary Supplement: placebo
a similar amount of placebo will be given each day in capsules, starting the day of admission till the sixth postoperative day




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497978


Locations
Netherlands
Medical Center Alkmaar
Alkmaar, Noord-Holland, Netherlands, 1800 AM
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Principal Investigator: Alexander PJ Houdijk, MD, PhD Medical Center Alkmaar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexander P.J. Houdijk, MD, PhD, surgeon, Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT00497978     History of Changes
Other Study ID Numbers: TAUP03.04.07/2
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

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