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Non Invasive Cardiac Output Monitoring to Guide Goal Directed Fluid Therapy in High Risk Patients Undergoing Urgent Surgical Repair of Proximal Femoral Fractures

NCT02382185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-07-02

No results posted yet for this study

Summary

Improving or maximising cardiac output in the perioperative setting through the use of goal directed fluid therapy has been shown to reduce complications and length of hospital stay in patients undergoing major abdominal surgery. The evidence for patients having surgery to repair a fractured neck of femur is less robust but many of these latter patients are elderly and often at high risk of complications.

Patients undergoing surgery (including surgery for hip fracture) under spinal anaesthesia have not had access to goal directed fluid therapy because of the invasive nature of the existing monitoring technology such as oesophageal doppler. The availability of a non invasive cardiac monitoring device, the Clearsight™, now makes goal directed fluid therapy a possibility for this group of patients.

This is a randomised controlled, observer blinded trial to assess the effects of goal directed fluid therapy in high-risk patients undergoing surgical repair of proximal femoral fractures.

The aim of the trial is to test the hypothesis that maximising circulating volume intra-operatively with balanced crystalloid reduces post-operative morbidity in high-risk patients undergoing urgent surgical repair of proximal femoral fractures.

Conditions

  • Hip Fractures

Interventions

OTHER

Fluid optimisation

The intervention will consist of optimising stroke volume with 250ml of Hartmanns solution

DRUG

Optimisation of blood pressure

Phenylephrine infusion will be used to target a mean arterial blood pressure to within 30% of baseline (preoperative) value

DEVICE

Application of clearsight monitor

The clear sight monitor will be applied to measure stroke volume.

Sponsors & Collaborators

  • York Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Simon Davies, MB FRCA MD · York Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-09-28
Completion
2017-09-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02382185 on ClinicalTrials.gov