Supernormal Goal for Proximal Femur Fracture

July 16, 2014 updated by: Xiangcai Ruan, Guangzhou First People's Hospital

Supernormal Oxygen Delivery May Not be a Valid Goal for Patients With Proximal Femur Fracture. An Observational Pilot Study

This is an observational pilot study of supernormal oxygen delivery goal for patients with proximal femoral fracture.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Augmentation of oxygen delivery using fluids with or without inotropes has been shown to improve surgical outcome in high-risk patients. Patients with proximal femoral fracture are considered high risk. However, most of this cohort elderly patients have poor cardiovascular condition and may not achieve the oxygen delivery goal. We will perform an observational pilot study whether the supernormal oxygen delivery is a valid hemodynamic goal for patients with proximal femoral fracture.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First Municipal People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be aged over 70 yr and weight over 35 kg, and undergoing proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.

Description

Inclusion Criteria:

  • Patients aged over 70 yr
  • Weight over 35 kg
  • Underwent proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.

Exclusion Criteria:

  • Patients who could be harmed due to the treatment (ongoing myocardial infarction, chronic dialysis)
  • Monoamine oxidase inhibitor use within the last 14 days
  • Pathological fractures and conditions
  • Inability to give informed consent(as judged by a research team member)
  • Anticipated difficulties obtaining data during the first postoperative year (as judged by a research team member)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Supernormal oxygen delivery goal therapy
Patients will be aged over 70 yr and weight over 35 kg, and undergoing proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.
Procedure: Supernormal oxygen delivery goal therapy
A 10% increase in stroke volume (SV) after fluid challenge (5 ml/kg) with Ringer's lactate solution will be deemed positive. Oxygen delivery will be check when fluid challenge becomes negative. If oxygen delivery index (DO2I) can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 10 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxgen delivery index
Time Frame: At the end of 4 hour goal-directed therapy
To attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy
At the end of 4 hour goal-directed therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Day 30
Day 30
Hear rate augmentation
Time Frame: Day 1
Day 1
Hemodynamic response
Time Frame: Day 1
Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.
Day 1
fluid volume administrated
Time Frame: intraoperatively
intraoperatively
Postoperative morbidity
Time Frame: day 5
day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou First People's Hospital

Investigators

  • Principal Investigator: Xiangcai Ruan, MD., PhD., Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZFPH-IRB-2013-049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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