NCT00444262

Brief Summary

The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
215

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2007

Typical duration for phase_3

Geographic Reach
1 country

19 active sites

Status
terminated

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

March 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 7, 2011

Status Verified

June 1, 2011

Enrollment Period

3.6 years

First QC Date

March 6, 2007

Last Update Submit

October 6, 2011

Conditions

Hip Fractures

Keywords

Hemodynamic optimisationEsophageal DopplerHydroxy ethyl starchHip fractureOutcomeElderly subjects (≥ 70 year old)General anesthesia

Outcome Measures

Primary Outcomes (1)

  • We expect a 30% reduction in the number of per- and post-operative complications observed during hospitalisation in acute care beds in the "optimised" subgroup with respect to "conventional" subgroup. Complications include: death, per-operative

    during hospitalisation in acute care

Secondary Outcomes (1)

  • We will check if patients in the "optimised" group have:1) a reduction in the delay to walk without help2) more days " out-of-hospital " at 3 months 3) a reduction in 1-year mortality rate

    at 3 months and at one year

Study Arms (2)

1

ACTIVE COMPARATOR

conventional treatment

Drug: VOLUVEN and others solute

2

EXPERIMENTAL

stroke volume optimisation

Procedure: hemodynamic optimisation guided using esophageal Doppler

Interventions

hemodynamic optimisation guided using esophageal DopplerPROCEDURE

hemodynamic optimisation guided using esophageal Doppler

2
VOLUVEN and others soluteDRUG

VOLUVEN and others solute

1

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly subjects (≥ 70 year old) with hip fracture

You may not qualify if:

  • Patient or legal representative unwilling to give informed consent
  • Patient with other trauma lesions associated to hip fracture
  • Patient with esophageal disease or chronic dissection of the descending aorta (contra-indications to esophageal Doppler monitoring)
  • Patient with known active neoplasia or with obvious metastatic hip fracture
  • Allergy to hydroxy-ethyl starches
  • Congenital hemostatic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Centre Hospitalier Universitaire de La Cote de Nacre

Caen, Calvados, 14000, France

Location

Hopital Purpan

Toulouse, Haute Garonne, 31000, France

Location

Hopital Antoine Beclere

Clamart, Hauts de Seine, 92140, France

Location

Hopital D'Instruction Des Armees Percy

Clamart, Hauts de Seine, 92140, France

Location

Hopital Beaujon

Clichy, Hauts de Seine, 92110, France

Location

Hopital Lapeyronie

Montpellier, Herault, 34000, France

Location

Hopital Lariboisiere

Paris, Paris, 75010, France

Location

Hopital Saint Antoine

Paris, Paris, 75012, France

Location

Hopital La Pitie Salpetriere

Paris, Paris, 75013, France

Location

Fondation Saint Joseph

Paris, Paris, 75014, France

Location

Hopital Cochin

Paris, Paris, 75014, France

Location

Hopital Europeen Georges Pompidou

Paris, Paris, 75015, France

Location

Hopital Bichat

Paris, Paris, 75018, France

Location

Centre Hospitalier de Meaux

Meaux, Seine Et Marne, 77100, France

Location

Centre Hospitalier Universitaire Rouen

Rouen, Seine Maritime, 76000, France

Location

Hopital Avicenne

Bobigny, Seine Saint Denis, 93009, France

Location

Hopital Henri Mondor

Créteil, Val de Marne, 94000, France

Location

Hopital Bicetre

Le Kremlin-Bicêtre, Val de Marne, 94275, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne, 86000, France

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

HES 130-0.4

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • bernard CHOLLEY, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 7, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2010

Study Completion

March 1, 2011

Last Updated

October 7, 2011

Record last verified: 2011-06

Locations

FR(19)