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Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joachim Zdolsek, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01115166
First received: May 3, 2010
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is subjected to large changes. The purpose of this study is to see if it is possible with the help of volume kinetic techniques to use these variations to measure blood volume and fluid escape from the intravascular volume.


Condition
Blood Volume, Extravasation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Blood Volume [ Time Frame: 30 minutes after start of CPB ] [ Designated as safety issue: No ]

    volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.

    1. The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.
    2. The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.

    To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated.



Secondary Outcome Measures:
  • Intracellular Edema [ Time Frame: 30 minutes after CPB ] [ Designated as safety issue: No ]

    Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.

    A positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass.



Other Outcome Measures:
  • Fluid Extravasation [ Time Frame: Two distribution half-times. Approximately 16 minutes. ] [ Designated as safety issue: No ]
    Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.


Enrollment: 10
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac surgery
Patients subjected to open cardiac surgery with the help of extracorporal circulation.

Detailed Description:

In many clinical situations, such as extensive surgery, it is of value to determine blood volume and rate of fluid loss from the intravascular space, since hypo- and hypervolemia are combined with increased morbidity and mortality. In this study we which to use the large variations in hemoglobin during extracorporal to calculate both these variables.

Hemoglobin is measured every 5 minutes during one hour beginning shortly before start of the heart-lung machine. When the extracorporal circulation begins the hemoglobin decreases due to the quick mix and dilution of the priming fluid from the heart-lung machine with the patients blood.

From the amount of priming fluid and the fall of the hemoglobin, the blood volume can be calculated. If no further fluid is given the next 20 to 30 minutes, the hemoglobin concentration will in most cases increase as a result of the fluid loss from the vascular space. This increase in combination with the diureses can be used to calculate the intravascular fluid loss to the interstitium during surgery.

Sodium concentration will also be measured in parallel with the hemoglobin concentration.

The Sodium concentrations in combination with given and excreted (urine)Sodium can be used in a mass balance to calculate if intracellular edema is induced.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients subjected to open cardiac surgery, with the help of extracorporal circulation.

Criteria

Inclusion Criteria:

  • open heart surgery, with extracorporal circulation
  • consent to participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115166

Locations
Sweden
University Hospital, Thoracic operation ward
Linkoeping, Sweden, 581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Joachim Zdolsek, MD, PhD University Hospital, Linköping, Sweden
  More Information

No publications provided

Responsible Party: Joachim Zdolsek, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01115166     History of Changes
Other Study ID Numbers: BVECC
Study First Received: May 3, 2010
Results First Received: May 11, 2012
Last Updated: September 6, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
blood volume

ClinicalTrials.gov processed this record on November 25, 2014