Clinical trial NCT02470221: Goal-directed Intraoperative Fluid Therapy in High-risk Surgery
Official title: Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Fluid Overload
Keywords: goal-directed fluid therapy
intraoperative hemodynamics
postoperative complications
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent either laparotomy of gynecological malignancies or orthopedic surgery

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.

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.

Eligibility 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.

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days after the surgery
Secondary outcomes:
measure: hospital length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: hospital expenses
timeFrame: 30 days after the surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuguang Huang, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.