NCT01473446

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

November 14, 2011

Last Update Submit

March 27, 2015

Conditions

Postoperative Complications

Keywords

Goal directed fluid therapyperioperative fluid therapyLiDCOrapidPostoperative outcomeOpen abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    5 days after surgery

Secondary Outcomes (5)

  • Length of hospital stay

    3 month after surgery

  • Complications until discharge and readmission within 30 days

    3 month after surgery

  • Mortality within 30 days and 3-month after surgery

    3 month after surgery

  • Renal function

    5 days after surgery

  • Vasoactive agents need

    3 month after surgery

Study Arms (2)

Control

NO INTERVENTION

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.

Goal directed fluid therapy

EXPERIMENTAL
Procedure: Goal directed fluid therapy guided by LiDCOrapid

Interventions

Goal directed fluid therapy guided by LiDCOrapidPROCEDURE

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.

Goal directed fluid therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ASA class III \& IV (high risk) patients
  • \>18 years
  • scheduled for gastrointestinal surgery involving laparotomy
  • Both elective and emergency cases

You may not qualify if:

  • Atrial fibrillation
  • Mental impairment, unable to give informed consent
  • Severe aortic or mitral stenosis
  • Type of surgery: Liver surgery, transthoracic oesophagectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oulu University Hospital, Department of Anesthesia and Intensive Care

Oulu, 90029, Finland

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Stavanger Universityhospital, Division for medical service, anesthesia and intensive care

Stavanger, 4011, Norway

Location

Related Publications (1)

  • 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.

    PMID: 26203353DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ib Jammer, MD

    Helse Bergen HF, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Last Updated

March 30, 2015

Record last verified: 2013-03

Locations

FI(1)NO(2)