NCT02194101

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
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Guangzhou First People's Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Fractures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2014-07-18
• Last updated: 2014-07-18

Locations

1 site across 1 country: China