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Non Invasive Methods to Guide Volume Optimization

NCT01458678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-09-17

No results posted yet for this study

Summary

Goal directed volume therapy means that bolus doses of 150-250 ml colloid fluid is administered to the patient during contemporary measurement of the patients stroke volume. The fluid status is considered optimized when stroke volume no longer increases with more than 10%, indicating that the patient is close to the top of the Frank-Starling curve. Several studies show that volume optimization reduces hospital stay and reduces the amount of surgical complications. The overall purpose is to investigate if the much more simple non invasive technique Pleth Variability Index can replace oesophageal doppler to guide volume therapy in routine health care, and to analyse if a volume kinetic test can be used to evaluate hypovolemia before surgery and make specific rehydration possible by analysing the correlation between this test and fluid optimization using stroke volume measurements.

Primary hypothesis: 1. The volume of colloids that is given to volume optimise an anesthetized patient using Pleth Variability Index shows a good correlation to the volume used if volume optimisation is undertaken by the guidance of oesophageal doppler. 2. Data from the two methods correlate and discriminates similarly volume responders from non responders. 3. A volume kinetic model that indicates dehydration can predict the need for rehydration in order to achieve a well hydrated patient at start of surgery.

Conditions

  • Postoperative Complications

Interventions

OTHER

Volume of colloid infusion

Colloid infusion is primarily given as hydroxyethyl starch 60 mg/ml. If more than 30 ml/kg hydroxyethyl starch 60 mg/ml is given, colloid solution is changed to albumin 4% or plasma.

OTHER

Volume of colloid infusion

Colloid infusion is given primarily as hydroxyethyl starch 60 mg/ml. If more than 30 ml/kg hydroxyethyl starch 60 mg/ml is given, colloid solution is changed to albumin 4% or plasma.

Sponsors & Collaborators

  • Lena Nilsson

    lead OTHER

Principal Investigators

  • Lena Nilsson, MD PhD · Anestesi- och operationskliniken, Universitetssjukuset, SE 58183 Linköping, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458678 on ClinicalTrials.gov