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

NCT ID: NCT00497978

Last Updated: 2011-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-10-31

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.

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.

Conditions

Insulin Resistance; Elderly Patient; Oxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

1

taurine will be given per capsule

Group Type: ACTIVE_COMPARATOR

taurine

Intervention Type: DIETARY_SUPPLEMENT

6 grams of taurine will be given each day in capsules, starting the day of admission till the sixth postoperative day

2

placebo capsules containing microcrystalline cellulose will be given

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

a similar amount of placebo will be given each day in capsules, starting the day of admission till the sixth postoperative day

Interventions

taurine

6 grams of taurine will be given each day in capsules, starting the day of admission till the sixth postoperative day

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: lead

Responsible Party

Alexander P.J. Houdijk

MD, PhD, surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander PJ Houdijk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Alkmaar

Locations

Medical Center Alkmaar

Alkmaar, North Holland, Netherlands

Countries

Netherlands

References

Westhoff D, Witlox J, Koenderman L, Kalisvaart KJ, de Jonghe JF, van Stijn MF, Houdijk AP, Hoogland IC, Maclullich AM, van Westerloo DJ, van de Beek D, Eikelenboom P, van Gool WA. Preoperative cerebrospinal fluid cytokine levels and the risk of postoperative delirium in elderly hip fracture patients. J Neuroinflammation. 2013 Oct 7;10:122. doi: 10.1186/1742-2094-10-122.

Reference Type: DERIVED

PMID: 24093540 (View on PubMed)

Witlox J, Slor CJ, Jansen RW, Kalisvaart KJ, van Stijn MF, Houdijk AP, Eikelenboom P, van Gool WA, de Jonghe JF. The neuropsychological sequelae of delirium in elderly patients with hip fracture three months after hospital discharge. Int Psychogeriatr. 2013 Sep;25(9):1521-31. doi: 10.1017/S1041610213000574. Epub 2013 May 7.

Reference Type: DERIVED

PMID: 23651760 (View on PubMed)

Slor CJ, Witlox J, Jansen RW, Adamis D, Meagher DJ, Tieken E, Houdijk AP, van Gool WA, Eikelenboom P, de Jonghe JF. Affective functioning after delirium in elderly hip fracture patients. Int Psychogeriatr. 2013 Mar;25(3):445-55. doi: 10.1017/S1041610212001962. Epub 2012 Nov 30.

Reference Type: DERIVED

PMID: 23194775 (View on PubMed)

Other Identifiers

TAUP03.04.07/2

Identifier Type: -

Identifier Source: org_study_id