Clinical trial NCT02629250: Supernormal Oxygen Delivery for Elderly Surgical Patients
Official title: A Randomized Controlled Study of Supernormal Oxygen Delivery Goal-directed Therapy for Elderly Patients Undergoing Proximal Femoral Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Fractures
Keywords: proximal femoral fracture
goal-directed therapy
myocardial injury
supernormal oxygen delivery
elders
stroke volume maximization
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery \[1\]. 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 \[2-7\]. The maintenance of adequate tissue perfusion and global oxygen delivery (DO2I) is essential to maintain adequate tissue perfusion and oxygenation in relation to increased metabolic demand during high risk surgery. However, there is concern that inotropic therapy for a supernormal oxygen delivery may lead to an increased incidence of myocardial ischemia \[8\]. Even though the meta-analysis has stated that DO2I optimization could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy \[9\],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. The investigators will conduct a prospective, randomized, controlled, double-blinded trial in seventy patients who scheduled for proximal femur surgery under General anesthesia following nerve block. Both the patients will be allocated to one of two equal groups to receive either intraoperative fluid regimen guided by SV strategy or DO2I strategy. In the control(SV) group, the patients will receive an intravenous infusion of 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume maximization. In the experimental(DO2I) group, fluid and dobutamine will be given to reach a stroke volume maximization and supernormal oxygen delivery. The primary outcome is preoperative and 24h postoperative serum concentration of troponin T. Secondary outcomes include the incidence of tachycardia, arrhythmia, myocardial infarction, pneumonedema and acute heart failure, blood pressure, pulmonary infection, fluid volume, blood transfusion volume, renal function, PONV, Length of postoperative hospital stay and mortality. Data will be collected and recorded by the clinical teams who are blind to study arm allocation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patient age \< 70 yrs
2. Ongoing myocardial infarct or ischemia
3. Chronic haemodialysis
4. Inability to cooperate in the study
5. Patient refusal

Primary outcomes:
measure: Change from baseline in concentration of troponin T at 24 hours postoperatively
timeFrame: preoperative value and 24 hours postoperatively
Secondary outcomes:
measure: cardiac complication up to 24 hours postoperatively
timeFrame: up to 24 hours postoperatively
measure: blood pressure
timeFrame: up to 24 hours postoperatively
measure: heart rate (HR)
timeFrame: up to 24 hours postoperatively
measure: SpO2
timeFrame: up to 24 hours postoperatively
measure: fluid balance
timeFrame: up to 24hours after surgery
measure: blood transfusion volume
timeFrame: up to 24 hours postoperatively
measure: Acute Kidney Injury
timeFrame: up to 24 hours postoperatively
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 hours postoperatively
measure: length of postoperative hospital stay
timeFrame: 28 days postoperatively
measure: mortality
timeFrame: 28 days postoperatively
measure: cardiac complication at 28 days postoperatively
timeFrame: 28 days postoperatively
measure: incidence of pulmonary infection
timeFrame: up to 28 days postoperatively
Other outcomes:
measure: Postoperative pain
timeFrame: 24 hours postoperatively
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital
name: Xiangcai Ruan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.