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Supernormal Oxygen Delivery for Elderly Surgical Patients

NCT02629250 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-02-16

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Guangzhou First People's Hospital

    lead OTHER

Principal Investigators

  • Xiangcai Ruan, MD, PhD · Guangzhou First People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-02-28
Completion
2017-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02629250 on ClinicalTrials.gov