The Importance of Albumin Infusion Rate for Plasma Volume Expansion Following Major Abdominal Surgery (AIR)
|ClinicalTrials.gov Identifier: NCT02728921|
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 19, 2017
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Change in plasma volume [ Time Frame: From start of infusion until 3 hours after start of infusion ]
- 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
- Incidence of postoperative complications [ Time Frame: 30 days postoperatively ]
- Transcapillary escape rate (TER) for albumin [ Time Frame: 180-240 min after start of infusion ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728921
|Skåne University Hospital, Region Skåne|
|Principal Investigator:||Peter Bentzer, MD||Region Skåne|