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Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

This study has been terminated.
(High exclusion rate)
Information provided by (Responsible Party):
Haukeland University Hospital Identifier:
First received: November 14, 2011
Last updated: March 27, 2015
Last verified: March 2013

November 14, 2011
March 27, 2015
January 2012
December 2013   (Final data collection date for primary outcome measure)
Postoperative complications [ Time Frame: 5 days after surgery ]
Same as current
Complete list of historical versions of study NCT01473446 on Archive Site
  • 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.
Same as current
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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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Complications
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.

  • 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
    Intervention: Procedure: Goal directed fluid therapy guided by LiDCOrapid
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Finland,   Norway
2011/947/REK Vest
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Haukeland University Hospital
Haukeland University Hospital
Not Provided
Study Chair: Ib Jammer, MD Helse Bergen HF, Norway
Haukeland University Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP