Supernormal Goal for Proximal Femur Fracture

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Guangzhou First Municipal People’s Hospital
Sponsor:
Information provided by (Responsible Party):
Xiangcai Ruan, Guangzhou First Municipal People's Hospital
ClinicalTrials.gov Identifier:
NCT02194101
First received: July 14, 2014
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Femoral Fractures
Procedure: Supernormal oxygen delivery goal therapy

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Guangzhou First Municipal People’s Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02194101

Contacts
Contact: Xiangcai Ruan, MD, PhD +8620-81048306 xc_ruan@hotmail.com
Contact: Jingwen Guo

Locations
China, Guangdong
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510180
Sponsors and Collaborators
Guangzhou First Municipal People’s Hospital
Investigators
Principal Investigator: Xiangcai Ruan, MD., PhD. Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180
  More Information

Publications:

Responsible Party: Xiangcai Ruan, Vice-Chair, Guangzhou First Municipal People's Hospital
ClinicalTrials.gov Identifier: NCT02194101     History of Changes
Other Study ID Numbers: GZFPH-IRB-2013-049
Study First Received: July 14, 2014
Last Updated: July 16, 2014
Health Authority: China: Health and Family Planning Commission of Guangdong Province

Keywords provided by Guangzhou First Municipal People’s Hospital:
oxygen delivery
proximal femoral fracture
goal-directed therapy

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on October 16, 2014