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Supernormal Goal for Proximal Femur Fracture

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02194101
Enrollment
30
Registered
2014-07-18
Start date
2014-08-31
Completion date
2015-06-30
Last updated
2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Fractures

Keywords

oxygen delivery, proximal femoral fracture, goal-directed therapy

Brief summary

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

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.

Interventions

PROCEDURESupernormal 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.

Sponsors

Guangzhou First People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Oxgen delivery indexAt the end of 4 hour goal-directed therapyTo attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy

Secondary

MeasureTime frameDescription
Hear rate augmentationDay 1
Hemodynamic responseDay 1Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.
fluid volume administratedintraoperatively
Length of hospital stayDay 30
Postoperative morbidityday 5

Countries

China

Contacts

Primary ContactXiangcai Ruan, MD, PhD
xc_ruan@hotmail.com+8620-81048306
Backup ContactJingwen Guo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026