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The Importance of Albumin Infusion Rate for Plasma Volume Expansion Following Major Abdominal Surgery (AIR)

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ClinicalTrials.gov Identifier: NCT02728921
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Region Skane

Brief Summary:

To study if plasma volume expansion is influenced by the rate at which a colloidal solution is administered in patients with a systemic inflammatory response induced by major abdominal surgery.

Randomization will be performed postoperatively at the day of surgery with a 1:1 ratio with no stratification and the study drug will be given as a slow (3 hours) or rapid (30 minutes) intravenous infusion.


Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Urogenital Neoplasm Systemic Inflammatory Response Syndrome Hypovolemia Drug: 5% Albumin infusion 30 min Drug: 5% Albumin infusion 3 hours Phase 4

Detailed Description:

Major surgery is one of many triggers of a systemic inflammatory response syndrome (SIRS), which disrupts the normal regulation of transcapillary fluid exchange with tissue oedema and hypovolemia as a consequence. Hypovolemia will amplify the inflammatory reaction by reducing cardiac output and oxygen delivery, which creates a vicious circle. Fluid therapy is therefore a cornerstone in the perioperative treatment patients subjected to major surgery. However, even if fluid therapy is life saving it is also associated with side effects such as further oedema formation, coagulopathy and further endothelial dysfunction.

From a clinical perspective, it is therefore important that the fluid administered to antagonize hypovolemia as far as possible remains intravascularly. Colloids are macromolecules for which the vessel wall has a low permeability and proponents of colloid containing fluids argues that less volume is required for equal plasma volume compared to crystalloids. However, extravasation of colloids is not only a function of the vessel wall permeability but is also dependent on the volume of fluid to that is filtered across the vascular wall, which in turn depends on the trans-capillary hydrostatic pressure. This means that administration of colloids in a way that minimizes the increase in capillary pressure could be important for the plasma volume expanding effect.

In support of this hypothesis is the experimental result that the plasma volume expansion of a colloidal solution can be affected by the rate of administration (Bark et al., 2013). If this finding proves to be valid also in a clinical setting, it will be very important for how colloidal solutions are prescribed in the clinic and may change current clinical practice in which suspected hypovolemia often is treated with a bolus infusion of fluid. This study intend to investigate whether these findings can be reproduced after a so-called Whipple's operation or after major gynaecological cancer surgery.

Study patients will be studied after these procedures because because they are large and standardized operations that trigger an inflammatory condition with capillary leakage and therefore can be considered as a model for major surgical procedures as well as ICU patients with SIRS triggered by for example sepsis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Importance of Albumin Infusion Rate for Plasma Volume Expansion. AIR. A Phase III Assessor Blinded Parallel Group Randomized Study
Study Start Date : April 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 5% Albumin infusion 30 min
Intravenous infusion of 5% Albumin at a dose of 10ml/kg during 30 min.
Drug: 5% Albumin infusion 30 min
Intravenous infusion of 5% Albumin at a dose of 10 ml/kg during 30 minutes. Dose is based on ideal weight.

Experimental: 5% Albumin infusion 3 hours
Intravenous infusion of 5% Albumin at a dose of 10ml/kg during 3 hours. Dose is based on ideal body weight
Drug: 5% Albumin infusion 3 hours
Intravenous infusion of 5% Albumin at a dose of 10 ml/kg during 3 hours. Dose is based on ideal weight.




Primary Outcome Measures :
  1. Change in plasma volume [ Time Frame: From start of infusion until 3 hours after start of infusion ]

Secondary Outcome Measures :
  1. Change in plasma volume over time [ Time Frame: From start of infusion until 3 hours after start of infusion ]
    Integral of plasma volume over time

  2. Incidence of postoperative complications [ Time Frame: 30 days postoperatively ]

Other Outcome Measures:
  1. Transcapillary escape rate (TER) for albumin [ Time Frame: 180-240 min after start of infusion ]
  2. Change in heart rate, change in central venous oxygen saturation, change in haemoglobin concentration in blood, change in blood pressure, change in central venous pressure, change in plasma lactate and diuresis. [ Time Frame: From start of infusion until 3 hours after start of infusion ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is scheduled for non-emergent Whipple operation or major gynaecological cancer surgery.
  2. Indication for fluid therapy as judged by the anaesthesiologist in charge and at least one at least one of the following criteria is fulfilled:

    • Positive "leg raising test" (pulse pressure increase > 9% or stroke volume increase by more than 10% as measured with cardiac ultrasound.
    • Central venous oxygen saturation (ScvO2) < 70%.
    • Plasma lactate > 2.0 mmol/l.
    • Urine output < 0.5 ml / kg for the latest hour.
    • Respiratory variation of the inferior vena cava of more than 15% as measured by ultrasound.
    • Systolic pressure < 100 mmHg, mean arterial pressure < 55 mmHg
  3. Age 40 and above
  4. Written consent by patient to participate in the study

Exclusion Criteria:

  1. Hypersensitivity to the active drug/ the tracer.
  2. Signs of postoperative bleeding.
  3. History of heart failure.
  4. The responsible physician considers that there are strong reasons to administrate another fluid or same fluid but in another way or in a different volume than those included in the protocol.
  5. Pregnancy
  6. Clinical judgment by the investigator or the treating physician that the patient should not participate in of the study for reasons other than described above.

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 ClinicalTrials.gov identifier (NCT number): NCT02728921


Locations
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Sweden
Skåne University Hospital, Region Skåne
Lund, Sweden
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Peter Bentzer, MD Region Skåne
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02728921    
Other Study ID Numbers: 2013-004446-42
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data collected in the current study will be available from the corresponding author on reasonable request.
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Urogenital Neoplasms
Systemic Inflammatory Response Syndrome
Hypovolemia
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Inflammation
Pathologic Processes
Shock