Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture

NCT01141894 | Terminated DMC

• 2 other identifiers: 2009-018087-10ID: 2008-1240-31
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to compare the costs and consequences of 'routine perioperative fluid therapy' and 'GDHT in terms of morbidity, mortality, length of hospital stay, activity of daily living, health related quality of life, cognitive functions and need of social services and up till 12 months following operations of proximal femoral fracture at elderly. The primary hypothesis is that 'GDHT is a better strategy than 'routine fluid therapy' in terms of reduced frequency of postoperative complications.

Conditions

Femoral Fracture

Keywords

Proximal Femoral Fracture

Outcome Measures

Primary Outcomes (1)

• number of patients with postoperative complications

  absolute value, number

  up to 2 weeks

Secondary Outcomes (6)

• Health Related Quality of Life

  1 year

• number of complications

  4 months

• number of complications

  12 months

• health related quality of life

  4 months

• health related quality of life

  12 months

Study Arms (2)

Routine fluid treatment

ACTIVE COMPARATOR

Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h and additionally as needed Voluven at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension

Other: Routine fluid treatment

Goal directed haemodynamic treatment

EXPERIMENTAL

Goal directed haemodynamic treatment Dobutamine 0.2-10 μg/kg/min Buffered Glucose 25 mg/ml 1ml/kg/h Ringer's Acetate 2 ml/kg/h Voluven 3 ml/kg as fluid challenge at the attending anaesthetist's discretion Phenylephrine 50 μg for correction of hypotension

Other: Goal directed haemodynamic treatment

Interventions

Goal directed haemodynamic treatment OTHER

Treatment by fluids and Dobutamine to attain fixed haemodynamic goal

Also known as: Dobutamine 0.2-10 μg/kg/min, Buffered Glucose 25 mg/ml 1 ml/kg/h, Ringer´s Acetate 2 ml/kg/h, Voluven 3 ml/kg as fluid challenge, Phenylephrine 50 μg for correction of hypotension

Goal directed haemodynamic treatment

Routine fluid treatment OTHER

Protocol guided fluid treatment used in the clinical routine

Also known as: Buffered Glucose 25 mg/ml 1ml/kg/h, Ringer´s Acetate 2 ml/kg/h, Voluven at the attending anaesthetist's discretion, Phenylephrine 50 μg for correction of hypotension

Routine fluid treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients (men and women) age ≥ 70 years
• Patients´ scheduled for operation of proximal femoral fracture during office hours
• Patient who have a witnessed or written informed consent

You may not qualify if:

• Concomitant medication with Lithium
• Known allergy (or hypersensitivity) to Lithium, or components of the medical device
• Weight ≤ 40 kg
• Other conditions or symptoms preventing the subject from entering the study, according to investigators judgment
• Life expectancy less than 6 months and/or pathological fractures
• Not possible to insert arterial line.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Huddinge, 14186, Sweden

Location

Related Publications (2)

• Bartha E, Arfwedson C, Imnell A, Kalman S. Towards individualized perioperative, goal-directed haemodynamic algorithms for patients of advanced age: observations during a randomized controlled trial (NCT01141894). Br J Anaesth. 2016 Apr;116(4):486-92. doi: 10.1093/bja/aew025.

  PMID: 26994228 DERIVED

• Bartha E, Davidson T, Brodtkorb TH, Carlsson P, Kalman S. Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients. Trials. 2013 Jul 9;14:205. doi: 10.1186/1745-6215-14-205.

  PMID: 23837606 DERIVED

MeSH Terms

Conditions

Femoral Fractures; Proximal Femoral Fractures

Interventions

Dobutamine; HES 130-0.4; Phenylephrine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Neck Fractures; Hip Fractures; Hip Injuries

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols

Study Officials

• Erzsebet Bartha, M.D

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: June 11, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

SE (1)