Goal-directed Intraoperative Fluid Therapy in High-risk Surgery

NCT02470221 | Completed

• 1 other identifier: anesthesiologyPUMCH001
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Complications; Fluid Overload

Keywords

goal-directed fluid therapy; intraoperative hemodynamics; postoperative complications

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  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）

  30 days after the surgery

Secondary Outcomes (2)

• hospital length of stay

  participants will be followed for the duration of hospital stay, an expected average of 10 days

• hospital expenses

  30 days after the surgery

Study Arms (2)

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

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

Interventions

Applying goal-directed fluid therapy by continuous hemodynamic monitoring system OTHER

Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

Goal-directed fluid therapy

Conventional fluid therapy OTHER

Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.

Conventional fluid therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent either laparotomy of gynecological malignancies or orthopedic surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huang YuGuang: lead

Related Publications (6)

• Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.

  PMID: 21624138 BACKGROUND

• Kuper M, Gold SJ, Callow C, Quraishi T, King S, Mulreany A, Bianchi M, Conway DH. Intraoperative fluid management guided by oesophageal Doppler monitoring. BMJ. 2011 May 24;342:d3016. doi: 10.1136/bmj.d3016.

  PMID: 21610051 BACKGROUND

• Wang P, Wang HW, Zhong TD. Effect of stroke volume variability- guided intraoperative fluid restriction on gastrointestinal functional recovery. Hepatogastroenterology. 2012 Nov-Dec;59(120):2457-60. doi: 10.5754/hge12283.

  PMID: 22626878 BACKGROUND

• Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.

  PMID: 23264068 BACKGROUND

• 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.

  PMID: 17925428 BACKGROUND

• Che L, Zhang XH, Li X, Zhang YL, Xu L, Huang YG. Outcome impact of individualized fluid management during spine surgery: a before-after prospective comparison study. BMC Anesthesiol. 2020 Jul 22;20(1):181. doi: 10.1186/s12871-020-01092-w.

  PMID: 32698766 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Edema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Yuguang Huang, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor，Chairman

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 12, 2015
• Study Start: March 1, 2016
• Primary Completion: February 10, 2018
• Study Completion: July 1, 2018
• Last Updated: May 31, 2019

Record last verified: 2019-05