NCT02194101

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

July 14, 2014

Last Update Submit

July 16, 2014

Conditions

Femoral Fractures

Keywords

oxygen deliveryproximal femoral fracturegoal-directed therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Hear rate augmentation

    Day 1

  • Hemodynamic response

    Day 1

  • fluid volume administrated

    intraoperatively

  • Length of hospital stay

    Day 30

  • Postoperative morbidity

    day 5

Study Arms (1)

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

Interventions

Supernormal oxygen delivery goal therapyPROCEDURE

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.

Supernormal oxygen delivery goal therapy

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients aged over 70 yr
  • Weight over 35 kg
  • Underwent proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Related Publications (8)

  • Pestana D, Espinosa E, Eden A, Najera D, Collar L, Aldecoa C, Higuera E, Escribano S, Bystritski D, Pascual J, Fernandez-Garijo P, de Prada B, Muriel A, Pizov R. Perioperative goal-directed hemodynamic optimization using noninvasive cardiac output monitoring in major abdominal surgery: a prospective, randomized, multicenter, pragmatic trial: POEMAS Study (PeriOperative goal-directed thErapy in Major Abdominal Surgery). Anesth Analg. 2014 Sep;119(3):579-587. doi: 10.1213/ANE.0000000000000295.

    PMID: 25010820RESULT

  • 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. No abstract available.

    PMID: 24841970RESULT

  • 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 postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.

    PMID: 24010849RESULT

  • 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 Dec 28.

    PMID: 23274782RESULT

  • 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.

    PMID: 21624138RESULT

  • 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.

    PMID: 21048092RESULT

  • 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 Anaesth. 2013 Oct;111(4):535-48. doi: 10.1093/bja/aet155. Epub 2013 May 9.

    PMID: 23661403RESULT

  • Bisgaard J, Gilsaa T, Ronholm 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.

    PMID: 22897633RESULT

MeSH Terms

Conditions

Femoral FracturesProximal Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesFemoral Neck FracturesHip FracturesHip Injuries

Study Officials

  • Xiangcai Ruan, MD., PhD.

    Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcai Ruan, MD, PhD

CONTACT

+8620-81048306xc_ruan@hotmail.com

Jingwen Guo

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-Chair

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 18, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

CN(1)