Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

Haukeland University Hospital

Status: Terminated

Conditions: Postoperative Complications

Treatments: Procedure: Goal directed fluid therapy guided by LiDCOrapid

Study type: Interventional

Funder types: Other

Identifiers

NCT01473446

2011/947/REK Vest

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Control

No Intervention group

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.

Goal directed fluid therapy

Experimental group

Treatment:

Procedure: Goal directed fluid therapy guided by LiDCOrapid