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Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473446
Recruitment Status : Terminated (High exclusion rate)
First Posted : November 17, 2011
Last Update Posted : March 30, 2015
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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.

Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 5 days after surgery ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 3 month after surgery ]
  2. Complications until discharge and readmission within 30 days [ Time Frame: 3 month after surgery ]
  3. Mortality within 30 days and 3-month after surgery [ Time Frame: 3 month after surgery ]
  4. Renal function [ Time Frame: 5 days after surgery ]
    defined by RIFLE criteria

  5. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473446

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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
Sponsors and Collaborators
Haukeland University Hospital
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Study Chair: Ib Jammer, MD Helse Bergen HF, Norway

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Haukeland University Hospital Identifier: NCT01473446    
Other Study ID Numbers: 2011/947/REK Vest
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2013
Keywords provided by Haukeland University Hospital:
Goal directed fluid therapy
perioperative fluid therapy
Postoperative outcome
Open abdominal surgery
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes