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

Tracking Information

First Received Date ^ICMJE

November 14, 2011

Last Updated Date

March 19, 2013

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

Official Title ^ICMJE

Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Complications

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland, Norway

Administrative Information

NCT Number ^ICMJE

NCT01473446

Other Study ID Numbers ^ICMJE

2011/947/REK Vest

Has Data Monitoring Committee

Responsible Party

Haukeland University Hospital

Study Sponsor ^ICMJE

Haukeland University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Ib Jammer, MD

Helse Bergen HF, Norway

Information Provided By

Haukeland University Hospital

Verification Date

March 2013

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

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