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Non Invasive Methods to Guide Volume Optimization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01458678
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : September 17, 2015
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Other: Volume of colloid infusion Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Non Invasive Methods for Goal Directed Fluid Therapy During Abdominal Surgery
Study Start Date : November 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. ml colloid infusion [ Time Frame: During surgery (2-8 hours) ]
    Volume colloid fluid to achieve volume optimisation for guidance using Pleth Variability Index and oesophageal doppler, respectively (comparison between groups)

  2. Correlation between ml colloid infusion and dehydration level [ Time Frame: During surgery (2-8 hours) ]
    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 :
  1. Days [ Time Frame: Days of hospital stay in connection with surgery, usually 2-10 days ]
    Length of hospital stay

  2. Complications (number) [ Time Frame: Complications occuring up to 30 days after surgery ]
    Number of complications using a prospective classification

  3. NT-pro-BNP [ Time Frame: Measured up to 2 days after surgery ]
    Cardiac stress measured by NT-pro-BNP

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 varicose veins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01458678

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Anestesi-och operationskliniken
Linköping, Sweden, SE - 581 85
Sponsors and Collaborators
Lena Nilsson
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Principal Investigator: Lena Nilsson, MD PhD Anestesi- och operationskliniken, Universitetssjukuset, SE 58183 Linköping, Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lena Nilsson, Senior consultant, PhD, University Hospital, Linkoeping Identifier: NCT01458678     History of Changes
Other Study ID Numbers: PVI vers OD
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes