Supernormal Goal for Proximal Femur Fracture
This is an observational pilot study of supernormal oxygen delivery goal for patients with proximal femoral fracture.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Supernormal Oxygen Delivery May Not be a Valid Goal for Patients With Proximal Femur Fracture. An Observational Pilot Study|
- Oxgen delivery index [ Time Frame: At the end of 4 hour goal-directed therapy ] [ Designated as safety issue: No ]To attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy
- Hear rate augmentation [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
- Hemodynamic response [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.
- fluid volume administrated [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- Postoperative morbidity [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02194101
|Contact: Xiangcai Ruan, MD, PhDfirstname.lastname@example.org|
|Contact: Jingwen Guo|
|Guangzhou First Municipal People's Hospital|
|Guangzhou, Guangdong, China, 510180|
|Principal Investigator:||Xiangcai Ruan, MD., PhD.||Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180|