Supernormal Oxygen Delivery for Elderly Surgical Patients

NCT ID: NCT02629250

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-03-31

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.

Conditions

Femoral Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SV maximization

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

Group Type: PLACEBO_COMPARATOR

SV maximization

Intervention Type: 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.

supernormal DO2

Goal-directed fluid therapy with stroke volume maximization and supernormal oxygen delivery.

Device: The Volume-View system from Edwards Co.

Group Type: EXPERIMENTAL

supernormal DO2

Intervention Type: 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.

Interventions

SV maximization

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.

Intervention Type: PROCEDURE

supernormal DO2

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.

Intervention Type: PROCEDURE

Other Intervention Names

Stroke volume maximization; Stroke volume maximization + supernormal oxygen delivery

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

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

Vice-Director in Dept Anesthesiology, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangcai Ruan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First People's Hospital

Locations

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangcai Ruan, MD, PhD

Role: CONTACT

xc_ruan@hotmail.com

+8620-81048306

Jingjing Tang

Role: CONTACT

15059038216@163.com

+8618898533061

Facility Contacts

Xiangcai Ruan, MD, PHD

Role: primary

xc_ruan@hotmail.com

86-20-81048306

References

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Reference Type: BACKGROUND

PMID: 7104132 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 20966436 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 16696864 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17925428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10213716 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16356219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17371601 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20920151 (View on PubMed)

Other Identifiers

GZZD-2015007

Identifier Type: -

Identifier Source: org_study_id