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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01473446
Enrollment
30
Registered
2011-11-17
Start date
2012-01-31
Completion date
Unknown
Last updated
2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Goal directed fluid therapy, perioperative fluid therapy, LiDCOrapid, Postoperative outcome, Open abdominal surgery

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.

Interventions

PROCEDUREGoal 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.

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative complications5 days after surgery

Secondary

MeasureTime frameDescription
Length of hospital stay3 month after surgery
Complications until discharge and readmission within 30 days3 month after surgery
Mortality within 30 days and 3-month after surgery3 month after surgery
Renal function5 days after surgerydefined by RIFLE criteria
Vasoactive agents need3 month after surgeryDifference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.

Countries

Finland, Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026