Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study

Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients?

The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.

Study Overview

• Status: Terminated
• Conditions: Postoperative Complications
• Intervention / Treatment: Procedure: Goal directed fluid therapy guided by LiDCOrapid

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90029
    • Oulu University Hospital, Department of Anesthesia and Intensive Care
• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Stavanger, Norway, 4011
    • Stavanger Universityhospital, Division for medical service, anesthesia and intensive care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult ASA class III & IV (high risk) patients
• >18 years
• scheduled for gastrointestinal surgery involving laparotomy
• Both elective and emergency cases

Exclusion Criteria:

• Atrial fibrillation
• Mental impairment, unable to give informed consent
• Severe aortic or mitral stenosis
• Type of surgery: Liver surgery, transthoracic oesophagectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard monitoring. Initial optimization of fluid status is performed by pulse, BP and anaesthesiologist assessment with Ringer acetate. Followed by an infusion of 10ml/kg/t Ringer acetate. Urinary output and blood pressure is used as a surrogate parameter: the infusion rate is increased by a fall in blood pressure or urine output <0.5ml/kg/t. Bleeding replaced with HES 1:1, otherwise see table for fluid therapy page 9. Vasoactive agents (noradrenaline / phenylephrine) is given if the anesthesiologist considers this necessary. Postoperative give 1000ml Glucose 5%. HES or Ringer when low blood pressure, eventually noradrenaline as vasoactive agent.
Experimental: Goal directed fluid therapy	Procedure: Goal directed fluid therapy guided by LiDCOrapid; Standard monitoring. The patient is connected to the LiDCOrapid monitor via an arterial line placed in a.radialis. A bolus of 500 ml Ringer acetate is given before anesthesia. If the stroke volume (SV) increases more than 10%, repeat the procedure until the SV is not increasing. After that, induction of anesthesia. Maintenance fluid is given as Ringer acetate 2ml/kg/t. Continuous monitoring of stroke volume variation (SVV). If SVV> 10%, give a fluid bolus 6ml/kg Ringer acetate. Repeat until SVV <10%. Bleeding is being replaced 1:1 with hydroxyethyl starch. SAG by bleeding >1000ml. By fall in blood pressure and SVV <10%, start vasoactive treatment with epinephrine. Postoperative is given Glucose 5% 80ml/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative complications	5 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		3 month after surgery
Complications until discharge and readmission within 30 days		3 month after surgery
Mortality within 30 days and 3-month after surgery		3 month after surgery
Renal function	defined by RIFLE criteria	5 days after surgery
Vasoactive agents need	Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.	3 month after surgery

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Study Chair: Ib Jammer, MD, Helse Bergen HF, Norway

Publications and helpful links

General Publications

• Jammer I, Tuovila M, Ulvik A. Stroke volume variation to guide fluid therapy: is it suitable for high-risk surgical patients? A terminated randomized controlled trial. Perioper Med (Lond). 2015 Jul 22;4:6. doi: 10.1186/s13741-015-0016-x. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Open abdominal surgery; Goal directed fluid therapy; Postoperative outcome; LiDCOrapid; perioperative fluid therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2011/947/REK Vest