Supernormal Goal for Proximal Femur Fracture

Femoral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02194101
• Other study ID #: GZFPH-IRB-2013-049
• Status: Not yet recruiting
• Phase: N/A
• First received: July 14, 2014
• Last updated: July 16, 2014
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2014
• Source: Guangzhou First Municipal People’s Hospital
• Contact: Xiangcai Ruan, MD, PhD
• Phone: +8620-81048306
• Email: xc_ruan[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou First Municipal People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First Municipal People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Bartha E, Arfwedson C, Imnell A, Fernlund ME, Andersson LE, Kalman S. Randomized controlled trial of goal-directed haemodynamic treatment in patients with proximal femoral fracture. Br J Anaesth. 2013 Apr;110(4):545-53. doi: 10.1093/bja/aes468. Epub 2012 — View Citation

Bennett-Guerrero E. Hemodynamic goal-directed therapy in high-risk surgical patients. JAMA. 2014 Jun 4;311(21):2177-8. doi: 10.1001/jama.2014.5306. — View Citation

Bisgaard J, Gilsaa T, Rønholm E, Toft P. Optimising stroke volume and oxygen delivery in abdominal aortic surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2013 Feb;57(2):178-88. doi: 10.1111/j.1399-6576.2012.02756.x. Epub 2012 Aug 17. — View Citation

Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30. — View Citation

Davies SJ, Yates D, Wilson RJ. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg. 2011 Jan;112(1):130-8. doi: 10.1213/ANE.0b013e3181fcea71. Epub 2010 Nov 3. — View Citation

Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane Systematic Review. Br J Ana — View Citation

Pestaña D, Espinosa E, Eden A, Nájera D, Collar L, Aldecoa C, Higuera E, Escribano S, Bystritski D, Pascual J, Fernández-Garijo P, de Prada B, Muriel A, Pizov R. Perioperative goal-directed hemodynamic optimization using noninvasive cardiac output monitor — View Citation

Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxgen delivery index	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	No
Secondary	Hear rate augmentation		Day 1	Yes
Secondary	Hemodynamic response	Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.	Day 1	No
Secondary	fluid volume administrated		intraoperatively	No
Secondary	Length of hospital stay		Day 30	No
Secondary	Postoperative morbidity		day 5	Yes