Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients
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|ClinicalTrials.gov Identifier: NCT01473446|
Recruitment Status : Terminated (High exclusion rate)
First Posted : November 17, 2011
Last Update Posted : March 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications||Procedure: Goal directed fluid therapy guided by LiDCOrapid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2013|
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.
- Postoperative complications [ Time Frame: 5 days after surgery ]
- Length of hospital stay [ Time Frame: 3 month after surgery ]
- Complications until discharge and readmission within 30 days [ Time Frame: 3 month after surgery ]
- Mortality within 30 days and 3-month after surgery [ Time Frame: 3 month after surgery ]
- Renal function [ Time Frame: 5 days after surgery ]defined by RIFLE criteria
- Vasoactive agents need [ Time Frame: 3 month after surgery ]Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473446
|Oulu University Hospital, Department of Anesthesia and Intensive Care|
|Oulu, Finland, 90029|
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Stavanger Universityhospital, Division for medical service, anesthesia and intensive care|
|Stavanger, Norway, 4011|
|Study Chair:||Ib Jammer, MD||Helse Bergen HF, Norway|