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Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

Primary Purpose

Postoperative Complications

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Goal directed fluid therapy guided by LiDCOrapid
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring Goal directed fluid therapy, perioperative fluid therapy, LiDCOrapid, Postoperative outcome, Open abdominal surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oulu University Hospital, Department of Anesthesia and Intensive Care
  • Haukeland University Hospital
  • Stavanger Universityhospital, Division for medical service, anesthesia and intensive care

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Goal directed fluid therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Postoperative complications

Secondary Outcome Measures

Length of hospital stay
Complications until discharge and readmission within 30 days
Mortality within 30 days and 3-month after surgery
Renal function
defined by RIFLE criteria
Vasoactive agents need
Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.

Full Information

First Posted
November 14, 2011
Last Updated
March 27, 2015
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01473446
Brief Title
Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients
Official Title
Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
High exclusion rate
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Goal directed fluid therapy, perioperative fluid therapy, LiDCOrapid, Postoperative outcome, Open abdominal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Goal directed fluid therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Goal directed fluid therapy guided by LiDCOrapid
Intervention Description
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 Measure Information:
Title
Postoperative complications
Time Frame
5 days after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
3 month after surgery
Title
Complications until discharge and readmission within 30 days
Time Frame
3 month after surgery
Title
Mortality within 30 days and 3-month after surgery
Time Frame
3 month after surgery
Title
Renal function
Description
defined by RIFLE criteria
Time Frame
5 days after surgery
Title
Vasoactive agents need
Description
Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.
Time Frame
3 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ib Jammer, MD
Organizational Affiliation
Helse Bergen HF, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Oulu University Hospital, Department of Anesthesia and Intensive Care
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Stavanger Universityhospital, Division for medical service, anesthesia and intensive care
City
Stavanger
ZIP/Postal Code
4011
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26203353
Citation
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.
Results Reference
derived

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Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

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