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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexander P.J. Houdijk, Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00497978
First received: July 6, 2007
Last updated: December 27, 2011
Last verified: December 2011
  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
Dietary Supplement: taurine
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Taurine on Morbidity and Mortality in the Elderly Hip Fracture Patient

Resource links provided by NLM:


Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:
  • morbidity and mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • antioxidant/oxidant parameters and inflammatory mediators [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • postoperative insulin resistance [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • mitochondrial dysfunction in the skeletal muscle [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • postoperative delirium incidence, duration and severity [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 236
Study Start Date: March 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Medical Center Alkmaar

Additional 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
Study First Received: July 6, 2007
Last Updated: December 27, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on July 24, 2014