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Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

This study has been terminated.
(High exclusion rate, therefore too few patients included within reasonable timeframe.)
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01473446
First received: November 14, 2011
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Postoperative Complications
 Procedure: Goal directed fluid therapy guided by LiDCOrapid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Postoperative complications [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]
  • Complications until discharge and readmission within 30 days [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]
  • Mortality within 30 days and 3-month after surgery [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]
  • Renal function [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
    defined by RIFLE criteria

  • Vasoactive agents need [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]
    Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.


Enrollment: 30
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473446

Locations
Finland
Oulu University Hospital, Department of Anesthesia and Intensive Care
Oulu, Finland, 90029
Norway
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
Investigators
Study Chair: Ib Jammer, MD Helse Bergen HF, Norway
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01473446     History of Changes
Other Study ID Numbers: 2011/947/REK Vest
Study First Received: November 14, 2011
Last Updated: March 19, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Goal directed fluid therapy
perioperative fluid therapy
LiDCOrapid
Postoperative outcome
Open abdominal surgery

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013