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Clinical Trials/NCT02629250
NCT02629250UnknownNot Applicable

A Randomized Controlled Study of Supernormal Oxygen Delivery Goal-directed Therapy for Elderly Patients Undergoing Proximal Femoral Surgery.

Guangzhou First People's Hospital1 site in 1 country70 target enrollmentStarted: December 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Change from baseline in concentration of troponin T at 24 hours postoperatively

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: preoperative value and 24 hours postoperatively

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

Secondary Outcomes

  • cardiac complication up to 24 hours postoperatively(up to 24 hours postoperatively)
  • fluid balance(up to 24hours after surgery)
  • heart rate (HR)(up to 24 hours postoperatively)
  • blood transfusion volume(up to 24 hours postoperatively)
  • length of postoperative hospital stay(28 days postoperatively)
  • mortality(28 days postoperatively)
  • cardiac complication at 28 days postoperatively(28 days postoperatively)
  • blood pressure(up to 24 hours postoperatively)
  • SpO2(up to 24 hours postoperatively)
  • Postoperative Nausea and Vomiting (PONV)(24 hours postoperatively)
  • incidence of pulmonary infection(up to 28 days postoperatively)
  • Acute Kidney Injury(up to 24 hours postoperatively)

Investigators

Sponsor
Guangzhou First People's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain

Vice-Director in Dept Anesthesiology, Professor

Guangzhou First People's Hospital

Study Sites (1)

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