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

November 14, 2011
March 19, 2013
January 2012
December 2013   (final data collection date for primary outcome measure)
Postoperative complications [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01473446 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
Not Provided
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Norway
 
NCT01473446
2011/947/REK Vest
No
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