Supernormal Oxygen Delivery for Elderly Surgical Patients

NCT02629250 | Unknown DMC

• 1 other identifier: GZZD-2015007
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery. Quite a few researches have shown the benefits of goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery. However there is concern that inotropic therapy for a supernormal oxygen delivery (DO2I) may lead to an increased incidence of myocardial ischemia. Even though the meta-analysis has stated that DO2I strategy could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy, there are very few evidence available in the literature regarding the effect on myocardial ischemia in surgical patients, especially in non-cardiac surgical patients. This study is undertaken to test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial ischemia in the elderly high-risk surgical patients.

Conditions

Femoral Fractures

Keywords

proximal femoral fracture; goal-directed therapy; myocardial injury; supernormal oxygen delivery; elders; stroke volume maximization

Outcome Measures

Primary Outcomes (1)

• Change from baseline in concentration of troponin T at 24 hours postoperatively

  Intraoperative supernormal oxygen delivery strategy will reduce the changes in concentration of troponin T at 24 hours postoperatively.

  preoperative value and 24 hours postoperatively

Secondary Outcomes (12)

• cardiac complication up to 24 hours postoperatively

  up to 24 hours postoperatively

• blood pressure

  up to 24 hours postoperatively

• heart rate (HR)

  up to 24 hours postoperatively

• SpO2

  up to 24 hours postoperatively

• fluid balance

  up to 24hours after surgery

Other Outcomes (1)

• Postoperative pain

  24 hours postoperatively

Study Arms (2)

SV maximization

PLACEBO COMPARATOR

Goal-directed fluid therapy with stroke volume maximization. Device: The Volume-View system from Edwards Co.

Procedure: SV maximization

supernormal DO2

EXPERIMENTAL

Goal-directed fluid therapy with stroke volume maximization and supernormal oxygen delivery. Device: The Volume-View system from Edwards Co.

Procedure: supernormal DO2

Interventions

SV maximization PROCEDURE

When SpO2 ≥92%, mean arterial pressure (MAP) 65-100 mmHg, HR \<100 bpm, Hb \>8mg/dL and temperature ≥36℃, the patients will receive a 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume (SV) maximization. The fluid challenge will repeat until the SV failed to increase by a factor of 10%. A reassessment on the SV maximization will be taken every 30 minutes and to restart algorithm when increased SV \>10% or blood loss \>250ml. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.

Also known as: Stroke volume maximization

SV maximization

supernormal DO2 PROCEDURE

Goal directed fluid therapy is administrated as group SV maximization. Then DO2I will be assessed. If at this stage the DO2I can not be greater than 600 mL/m2 (supernormal oxygen delivery goal), 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 20 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.

Also known as: Stroke volume maximization + supernormal oxygen delivery

supernormal DO2

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Adult patients scheduled for proximal femur fracture (PFF) surgery at this institution
• American Society of Anaesthesiologists (ASA) physical status of III or VI
• Two or more risk factors according to risk index of Lee

You may not qualify if:

• Patient age \< 70 yrs
• Ongoing myocardial infarct or ischemia
• Chronic haemodialysis
• Inability to cooperate in the study
• Patient refusal

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Related Publications (9)

• Fowkes FG, Lunn JN, Farrow SC, Robertson IB, Samuel P. Epidemiology in anaesthesia. III: Mortality risk in patients with coexisting physical disease. Br J Anaesth. 1982 Aug;54(8):819-25. doi: 10.1093/bja/54.8.819.

  PMID: 7104132 BACKGROUND

• Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.

  PMID: 20966436 BACKGROUND

• Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.

  PMID: 17822565 BACKGROUND

• Lobo SM, Lobo FR, Polachini CA, Patini DS, Yamamoto AE, de Oliveira NE, Serrano P, Sanches HS, Spegiorin MA, Queiroz MM, Christiano AC Jr, Savieiro EF, Alvarez PA, Teixeira SP, Cunrath GS. Prospective, randomized trial comparing fluids and dobutamine optimization of oxygen delivery in high-risk surgical patients [ISRCTN42445141]. Crit Care. 2006;10(3):R72. doi: 10.1186/cc4913. Epub 2006 May 12.

  PMID: 16696864 BACKGROUND

• Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.

  PMID: 17925428 BACKGROUND

• Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999 Apr 24;318(7191):1099-103. doi: 10.1136/bmj.318.7191.1099.

  PMID: 10213716 BACKGROUND

• Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.

  PMID: 16356219 BACKGROUND

• Pearse RM, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett D. The incidence of myocardial injury following post-operative Goal Directed Therapy. BMC Cardiovasc Disord. 2007 Mar 19;7:10. doi: 10.1186/1471-2261-7-10.

  PMID: 17371601 BACKGROUND

• Futier E, Vallet B. Inotropes in goal-directed therapy: do we need 'goals'? Crit Care. 2010;14(5):1001. doi: 10.1186/cc9251. Epub 2010 Sep 29.

  PMID: 20920151 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures; Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Neck Fractures; Hip Fractures; Hip Injuries

Study Officials

• Xiangcai Ruan, MD, PhD

  Guangzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcai Ruan, MD, PhD

CONTACT

+8620-81048306; xc_ruan@hotmail.com

Jingjing Tang

CONTACT

+8618898533061; 15059038216@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Director in Dept Anesthesiology, Professor

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 14, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

CN (1)