Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Procedure: Goal directed fluid therapy guided by LiDCOrapid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br> | Procedure: Goal directed fluid therapy guided by LiDCOrapid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Goal directed fluid therapy, perioperative fluid therapy, LiDCOrapid, Postoperative outcome, Open abdominal surgery