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

NCT02728921 | Completed Phase 4

• 1 other identifier: 2013-004446-42
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms; Urogenital Neoplasm; Systemic Inflammatory Response Syndrome; Hypovolemia

Outcome Measures

Primary Outcomes (1)

• Change in plasma volume

  From start of infusion until 3 hours after start of infusion

Secondary Outcomes (2)

• Change in plasma volume over time

  From start of infusion until 3 hours after start of infusion

• Incidence of postoperative complications

  30 days postoperatively

Other Outcomes (2)

• Transcapillary escape rate (TER) for albumin

  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.

  From start of infusion until 3 hours after start of infusion

Study Arms (2)

5% Albumin infusion 30 min

ACTIVE COMPARATOR

Intravenous infusion of 5% Albumin at a dose of 10ml/kg during 30 min.

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

Drug: 5% Albumin infusion 3 hours

Interventions

5% Albumin infusion 30 min DRUG

Intravenous infusion of 5% Albumin at a dose of 10 ml/kg during 30 minutes. Dose is based on ideal weight.

5% Albumin infusion 30 min

5% Albumin infusion 3 hours DRUG

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

5% Albumin infusion 3 hours

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital, Region Skåne

Lund, Sweden

Location

Related Publications (1)

• 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.

  PMID: 27923389 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Urogenital Neoplasms; Systemic Inflammatory Response Syndrome; Hypovolemia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Peter Bentzer, MD

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 5, 2016
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)