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Non Invasive Methods to Guide Volume Optimization

This study is currently recruiting participants.
Verified November 2011 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01458678
First received: October 20, 2011
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Complications
 Other: Volume of colloid infusion

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Open abdominal surgery under general anaesthesia with a planned operation time of at least 120 minutes
  2. Age ≥ 18 years

Exclusion Criteria:

  1. Anaesthesia risk classification ASA ≥ 4
  2. Arrhythmia; atrial fibrillation or multiple extra systoles
  3. Aortic - or mitral insufficiency with hemodynamic influence
  4. Patients who at the preoperative visit by the responsible anaesthesiologist is planned for a more advanced cardiovascular monitoring. The following monitoring is accepted in the study: invasive blood pressure, 5-lead ECG, central venous pressure and urinary output per hour.
  5. Patients with a pulmonary or other disease that prevents ventilation using a tidal volume of 7 ml/kg (ideal weight) or a positive end expiratory pressure of 5 -10 cm H2O
  6. Contra indication against synthetic colloids as severely impaired renal or liver function, hyper natremia or allergy to synthetic colloids
  7. Laparoscopic surgery
  8. Liver surgery
  9. Surgery including thoracotomy
  10. Contraindications against an oesophageal probe such as severe oesophageal varicous veins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458678

Contacts
Contact: Lena Nilsson, Md PhD +46 10 1031838 lena.nilsson@lio.se
Contact: Robert Hahn, Professor r.hahn@telia.com

Locations
Sweden
Anestesi-och operationskliniken Recruiting
Linköping, Sweden, SE - 581 85
Contact: Lena Nilsson, MD PhD     +46 - 10- 1031838     lena.nilsson@lio.se    
Contact: Robert Hahn, Professor         r.hahn@telia.com    
Sub-Investigator: Hans Bahlmann, MD            
Sponsors and Collaborators
Lena Nilsson
Investigators
Principal Investigator: Lena Nilsson, MD PhD Anestesi- och operationskliniken, Universitetssjukuset, SE 58183 Linköping, Sweden
  More Information

Publications:

Responsible Party: Lena Nilsson, Senior consultant, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01458678     History of Changes
Other Study ID Numbers: PVI vers OD
Study First Received: October 20, 2011
Last Updated: November 7, 2011
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013