Non Invasive Methods to Guide Volume Optimization
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 optimisation using stroke volume measurements.
Primary hypothesis: 1. The volume of colloids that is given to volume optimise an anesthetised 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of Non Invasive Methods for Goal Directed Fluid Therapy During Abdominal Surgery|
- ml colloid infusion [ Time Frame: During surgery (2-8 hours) ] [ Designated as safety issue: No ]Volume colloid fluid to achieve volume optimisation for guidance using Pleth Variability Index and oesophageal doppler, respectively (comparison between groups)
- Correlation between ml colloid infusion and dehydration level [ Time Frame: During surgery (2-8 hours) ] [ Designated as safety issue: No ]Correlation between level of dehydration measured by volume kinetics and urinary analysis, and correlation between these two circumstantials and the volume of colloids given for the first volume optimisation using Pleth Variability Index or oesophageal doppler
- Days [ Time Frame: Days of hospital stay in connection with surgery, usually 2-10 days ] [ Designated as safety issue: No ]Lenth of hospital stay
- Complications (number) [ Time Frame: Complications occuring up to 30 days after surgery ] [ Designated as safety issue: Yes ]Number of complications using a prospective classification
- NT-pro-BNP [ Time Frame: Measured up to 2 days after surgery ] [ Designated as safety issue: Yes ]Cardiac stress measured by NT-pro-BNP
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Oesophageal Doppler (OD)
Goal directed volume therapy is most often guided by stroke volume measurements by OD.
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.
Active Comparator: Pleth Variability Index (PVI)
The Pleth variability index (PVI) is an automated function in pulse oximetry that continuously calculates the dynamic variation between the pulse oximetry pulse variation and its baseline for every breathing circuit. Dynamic indicators are advantageous in predicting a responder to a volume bolus, thus facilitating goal directed volume therapy.
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458678
|Contact: Lena Nilsson, Md PhD||+46 10 firstname.lastname@example.org|
|Contact: Robert Hahn, Professoremail@example.com|
|Linköping, Sweden, SE - 581 85|
|Contact: Lena Nilsson, MD PhD +46 - 10- 1031838 firstname.lastname@example.org|
|Contact: Robert Hahn, Professor email@example.com|
|Sub-Investigator: Hans Bahlmann, MD|
|Principal Investigator:||Lena Nilsson, MD PhD||Anestesi- och operationskliniken, Universitetssjukuset, SE 58183 Linköping, Sweden|