Pancreatic NeoplasmsPhase 4AIRNCT02728921
The Importance of Albumin Infusion Rate for Plasma Volume Expansion Following Major Abdominal Surgery
A Phase 4 study testing 5% Albumin infusion 30 min and 5% Albumin infusion 3 hours in people with Pancreatic Neoplasms and Urogenital Neoplasm, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Urogenital Neoplasm, Systemic Inflammatory Response Syndrome
- What is being tested?
- 5% Albumin infusion 30 min and 5% Albumin infusion 3 hours
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is scheduled for non-emergent Whipple operation or major gynaecological cancer surgery.
- 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.
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- Respiratory variation of the inferior vena cava of more than 15% as measured by ultrasound.
- Systolic pressure < 100 mmHg, mean arterial pressure < 55 mmHg
- Age 40 and above
- Written consent by patient to participate in the study
Who cannot join
- Hypersensitivity to the active drug/ the tracer.
- Signs of postoperative bleeding.
- History of heart failure.
- 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.
- Pregnancy
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Albumin Infusion Rate for Plasma Volume Expansion. AIR. A Phase III Assessor Blinded Parallel Group Randomized Study
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.
Read the 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.
- Conditions
- Pancreatic Neoplasms, Urogenital Neoplasm, Systemic Inflammatory Response Syndrome, Hypovolemia
- Being tested
- 5% Albumin infusion 30 min, 5% Albumin infusion 3 hours
- Medical subject headings
- Pancreatic Neoplasms, Urogenital Neoplasms, Systemic Inflammatory Response Syndrome, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Albumin infusion 30 minDrug
Intravenous infusion of 5% Albumin at a dose of 10 ml/kg during 30 minutes. Dose is based on ideal weight.
5% Albumin infusion 3 hoursDrug
Intravenous infusion of 5% Albumin at a dose of 10 ml/kg during 3 hours. Dose is based on ideal weight.
| Study group | Role | What they receive |
|---|---|---|
| 5% Albumin infusion 30 min | Active comparator | Intravenous infusion of 5% Albumin at a dose of 10ml/kg during 30 min. Receives: Drug: 5% Albumin infusion 30 min |
| 5% Albumin infusion 3 hours | Experimental | Intravenous infusion of 5% Albumin at a dose of 10ml/kg during 3 hours. Dose is based on ideal body weight Receives: Drug: 5% Albumin infusion 3 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma volume
Measured: From start of infusion until 3 hours after start of infusion
Secondary outcomes (2)
Change in plasma volume over time
Integral of plasma volume over time
Measured: From start of infusion until 3 hours after start of infusion
Incidence of postoperative complications
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Bentzer, MD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728921
- Sponsor's protocol ID
- 2013-004446-42
- Acronym
- AIR
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data collected in the current study will be available from the corresponding author on reasonable request.
Publications
Statkevicius S, Bonnevier J, Bark BP, Larsson E, Oberg CM, Kannisto P, Tingstedt B, Bentzer P. The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery - AIR: study protocol for a randomised controlled trial. Trials. 2016 Dec 7;17(1):578. doi: 10.1186/s13063-016-1714-5.
PubMed 27923389
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Albumin Infusion Rate for Plasma Volume Expansion. AIR. A Phase III Assessor Blinded Parallel Group Randomized Study
- ClinicalTrials.gov ID
- NCT02728921
- Acronym / sponsor ID
- AIR / 2013-004446-42
- Conditions
- Pancreatic Neoplasms, Urogenital Neoplasm, Systemic Inflammatory Response Syndrome, Hypovolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% Albumin infusion 30 min | Active comparator | Drug: 5% Albumin infusion 30 minIntravenous infusion of 5% Albumin at a dose of 10ml/kg during 30 min. |
| 5% Albumin infusion 3 hours | Experimental | Drug: 5% Albumin infusion 3 hoursIntravenous infusion of 5% Albumin at a dose of 10ml/kg during 3 hours. Dose is based on ideal body weight |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient is scheduled for non-emergent Whipple operation or major gynaecological cancer surgery.
- Indication for fluid therapy as judged by the anaesthesiologist in charge and at least one at least one of the following criteria is fulfilled:
- Age 40 and above
- Written consent by patient to participate in the study
Key exclusion criteria (6 listed)
- Hypersensitivity to the active drug/ the tracer.
- Signs of postoperative bleeding.
- History of heart failure.
- 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.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% Albumin infusion 30 minIntravenous infusion of 5% Albumin at a dose of 10 ml/kg during 30 minutes. Dose is based on ideal weight. | Drug | 5% Albumin infusion 30 min |
| 5% Albumin infusion 3 hoursIntravenous infusion of 5% Albumin at a dose of 10 ml/kg during 3 hours. Dose is based on ideal weight. | Drug | 5% Albumin infusion 3 hours |
Primary outcome
Change in plasma volume
Time frame: From start of infusion until 3 hours after start of infusion
2 secondary outcomes
Change in plasma volume over time
Time frame: From start of infusion until 3 hours after start of infusion
Incidence of postoperative complications
Time frame: 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Derived from this study: PubMed 27923389Statkevicius S, Bonnevier J, Bark BP, Larsson E, Oberg CM, Kannisto P, Tingstedt B, Bentzer P. The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery - AIR: study protocol for a randomised controlled trial. Trials. 2016 Dec 7;17(1):578. doi: 10.1186/s13063-016-1714-5.
- Individual participant dataSharing planned: Yes. The data collected in the current study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bentzer, MD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5% Albumin infusion 30 min and 5% Albumin infusion 3 hours in people with Pancreatic Neoplasms and Urogenital Neoplasm, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma volume (time frame: From start of infusion until 3 hours after start of infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.