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Goal-directed Intraoperative Fluid Therapy in High-risk Surgery

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ClinicalTrials.gov Identifier: NCT02470221
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Huang YuGuang, Peking Union Medical College Hospital

Brief Summary:

This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost.

This is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. The details are described as follow.


Condition or disease Intervention/treatment
Postoperative Complications Fluid Overload Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system Other: Conventional fluid therapy

Detailed Description:

The study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in Peking Union Medical College Hospital. The study included two stages.

In the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. All the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. Specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. It is a standard procedure in Peking Union Medical College Hospital. Then, the incidence of postoperative complications of each group will be recorded. In addition, sample size will be estimated based on above study's results (estimated 100 participants).

In the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. The incidence of postoperative complications of each group will be recorded.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : February 10, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort Intervention/treatment
Goal-directed fluid therapy
The fluid in group Goal-directed fluid therapy will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system.
Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system
Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

Conventional fluid therapy
The fluid in group Conventional fluid therapy will be administered based on the principle crystalloid solution: colloid solution =2-3:1. The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient.
Other: Conventional fluid therapy
Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.




Primary Outcome Measures :
  1. postoperative complications [ Time Frame: 30 days after the surgery ]
    the incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting,postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine (N Engl J Med. 2009 Oct 1;361:1368-75)


Secondary Outcome Measures :
  1. hospital length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]
    the length of stay in hospital,from the hospitalized date to the leave date

  2. hospital expenses [ Time Frame: 30 days after the surgery ]
    total cost in hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients underwent either laparotomy of gynecological malignancies or orthopedic surgery
Criteria

Inclusion Criteria:

  1. Receiving elective laparotomy of gynecological malignancies (LGM): including cytoreductive surgery of ovarian cancer, radical hysterectomy and staging surgery of endometrial cancer ;
  2. Major elective orthopedic surgery (OS): including spinal surgery, revision surgery of hip joints ;
  3. Age ≥18 years, American Society of Anesthesiologists physical status I ~IV;
  4. No arrhythmia;
  5. Receiving general anesthesia;
  6. Requiring monitoring of direct blood pressure due to the comorbidities of patients and the nature of surgical procedures.

Exclusion Criteria:

  1. Emergent surgery;
  2. Patients with aortic regurgitation;
  3. Patients with aortic stenosis, peripheral arterial diseases or other diseases contradicting to arterial canalizations;
  4. Patients with mental disorders or low intelligence quotient; patients who cannot cooperate or refuse to sign the consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470221


Sponsors and Collaborators
Huang YuGuang
Investigators
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Study Chair: Yuguang Huang, MD Peking Union Medical College Hospital
Publications:
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Responsible Party: Huang YuGuang, Professor,Chairman, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02470221    
Other Study ID Numbers: anesthesiologyPUMCH001
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Keywords provided by Huang YuGuang, Peking Union Medical College Hospital:
goal-directed fluid therapy
intraoperative hemodynamics
postoperative complications
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes