Clinical trial · Observational

Goal-directed Intraoperative Fluid Therapy in High-risk Surgery

Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery

NCT02470221CI-TRIAL-00038863completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Fluid Overload	—	UNRESOLVED	—
Postoperative Complications	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Applying goal-directed fluid therapy by continuous hemodynamic monitoring system	Other	—	UNRESOLVED
Conventional fluid therapy	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Goal-directed fluid therapy
description
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.
interventionNames
1. Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system
label
Conventional fluid therapy
description
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.
interventionNames
1. Other: Conventional fluid therapy

Primary outcomes (1)

measure
postoperative complications
timeFrame
30 days after the surgery

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 90 Years

Show eligibility criteria text

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.

References

Publications (6)

BACKGROUNDCecconi 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
BACKGROUNDKuper 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
BACKGROUNDWang 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
BACKGROUNDRamsingh 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
BACKGROUNDDonati 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
DERIVEDChe 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