Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01473446
• Other study ID #: 2011/947/REK Vest
• Status: Terminated
• Phase: N/A
• First received: November 14, 2011
• Last updated: March 27, 2015
• Start date: January 2012

Study information

• Verified date: March 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
Finland	Oulu University Hospital, Department of Anesthesia and Intensive Care	Oulu
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger Universityhospital, Division for medical service, anesthesia and intensive care	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Countries where clinical trial is conducted

Finland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications		5 days after surgery	No
Secondary	Length of hospital stay		3 month after surgery	No
Secondary	Complications until discharge and readmission within 30 days		3 month after surgery	No
Secondary	Mortality within 30 days and 3-month after surgery		3 month after surgery	No
Secondary	Renal function	defined by RIFLE criteria	5 days after surgery	No
Secondary	Vasoactive agents need	Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.	3 month after surgery	No