NCT00497978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 30, 2011

Status Verified

December 1, 2011

Enrollment Period

3.6 years

First QC Date

July 6, 2007

Last Update Submit

December 27, 2011

Conditions

Insulin ResistanceElderly PatientOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • morbidity and mortality

    1 year

Secondary Outcomes (4)

  • antioxidant/oxidant parameters and inflammatory mediators

    1 week

  • postoperative insulin resistance

    1 week

  • mitochondrial dysfunction in the skeletal muscle

    1 week

  • postoperative delirium incidence, duration and severity

    1 week

Study Arms (2)

1

ACTIVE COMPARATOR

taurine will be given per capsule

Dietary Supplement: taurine

2

PLACEBO COMPARATOR

placebo capsules containing microcrystalline cellulose will be given

Dietary Supplement: placebo

Interventions

taurineDIETARY_SUPPLEMENT

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

1
placeboDIETARY_SUPPLEMENT

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

2

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Alkmaar

Alkmaar, North Holland, 1800 AM, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 24093540DERIVED

  • 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.

    PMID: 23651760DERIVED

  • 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.

    PMID: 23194775DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Taurine

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Alexander PJ Houdijk, MD, PhD

    Medical Center Alkmaar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, surgeon

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

March 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 30, 2011

Record last verified: 2011-12

Locations

NL(1)