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Glycocalyx Levels in Patients Undergoing Pancreatectomy

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ClinicalTrials.gov Identifier: NCT04058236
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Loh Pui San, University of Malaya

Brief Summary:

Background:

On the surface of every healthy cellular membrane resides a layer known as the glycocalyx. This structure consists of extracellular domains of receptor, adhesion and transmembrane molecules such as syndecan-1 covalently bound to highly negatively charged glycosaminoglycans, heparan sulfates. It has a principal role to maintain wall integrity, avoid inflammation and tissue oedema in vessels but in contrast, glycocalyx is robust and elevated on cancer cells. This study examines whether the endothelial glycocalyx layer is preserved in patients undergoing pancreatectomy with human albumin 5% vs. gelofusine in a restrictive goal directed fluid regime perioperatively for the first 24hours. Degradation of glycocalyx will be investigated by analyzing basic levels of the core protein syndecan-1 and heparan sulfates with post-operative samples.


Condition or disease Intervention/treatment Phase
Endothelial Degeneration Pancreatic Cancer Pancreatectomy Postoperative Pancreatic Fistula Other: human albumin 5% Other: gelofusine. Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial with Albumin 5% given as the intervention and Gelofusine as active control.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Randomized concealed assignment into 2 groups in opaque envelopes will be opened by care provider. Anaesthetic and ICU notes must not be revealed to outcome assessor.
Primary Purpose: Treatment
Official Title: Glycocalyx Levels in Patients Undergoing Pancreatectomy With Human Albumin 5% vs. Gelofusine
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: human albumin 5%
10 patients with pancreatic cancer will receive human albumin 5% in a restrictive goal directed fluid regime preoperatively for the first 24 hours.
Other: human albumin 5%
Human Albumin 5% will be given as fluid management for this group in accordance to goal directed therapy and guided by stroke volume variation of approximately 12-15%. This percentage of SVV has been validated as a threshold above which fluid administration increases stroke volume with an area under the receiver operating characteristics curve reported at 0.87. If the SVV remains more than 15% for more than 2 minutes, 250ml of fluid replacement according to patient group will be given. These boluses are given in aliquots over 30 min to avoid effects of rapid volume expansion. and the same fluid and technique will be carried out within 24 hours intra and post operatively in the Intensive Care Unit (ICU). All clinical parameters and fluids including blood that will be given will be recorded.
Other Name: Fluid management

Active Comparator: gelofusine
10 patients with pancreatic cancer will receive gelofusine in a restrictive goal directed fluid regime preoperatively for the first 24 hours.
Other: gelofusine.
Gelofusine will be given as fluid management for this group in accordance to goal directed therapy and guided by stroke volume variation of approximately 12-15%. This percentage of SVV has been validated as a threshold above which fluid administration increases stroke volume with an area under the receiver operating characteristics curve reported at 0.87. If the SVV remains more than 15% for more than 2 minutes, 250ml of fluid replacement according to patient group will be given. These boluses are given in aliquots over 30 min to avoid effects of rapid volume expansion. and the same fluid and technique will be carried out within 24 hours intra and post operatively in the Intensive Care Unit (ICU). All clinical parameters and fluids including blood that will be given will be recorded.
Other Name: Fluid management




Primary Outcome Measures :
  1. Occurence of pancreatic fistula leak [ Time Frame: Within post-op 30 days ]
    Review will be done according to guideline of Revised 2016 International Study Group on Pancreatic Fistula (ISGPF)

  2. Changes in serum syndecan 1 concentrations [ Time Frame: Within post-op 7 days ]
    Blood samples are collected to check for syndecan 1 concentrations in serum

  3. Changes in serum heparan sulfate concentrations [ Time Frame: Within post-op 7 days ]
    Blood samples are collected to check for heparan sulfate concentrations in serum


Secondary Outcome Measures :
  1. Changes in levels of Inflammatory markers Interleukin-1 and CRP [ Time Frame: Within post-op 7 days ]
    Blood samples are collected to check level of the Inflammatory markers Interleukin-1 and CRP



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1-3
  • patients aged between 18-75 years old with written informed consent

Exclusion Criteria:

  • Patients who refuse to participate,
  • Have severe congestive heart failure (NYHA class III/IV) or severe respiratory disease (PaO2/FiO2 < 200),
  • Suffer significant renal or hepatic dysfunction (creatinine raised >50 % or liver enzymes >50 % of normal values),
  • Pregnant
  • Allergic to gelofusine and human albumin

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): NCT04058236


Contacts
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Contact: Pui San Loh, MBBS, MMed 012-2268285 lohps@ummc.edu.my
Contact: Sook Hui Chaw, MD sook_hui@ummc.edu.my

Locations
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Malaysia
Anaesthesia Department, Faculty of Medicine, University Malaya
Kuala Lumpur, Federal Territory, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Pui San Loh, MBBS, MMed University Malaya, Malaysia

Publications:

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Responsible Party: Dr Loh Pui San, Consultant Anaesthesiologist, University of Malaya
ClinicalTrials.gov Identifier: NCT04058236     History of Changes
Other Study ID Numbers: U1111-1237-9121
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Loh Pui San, University of Malaya:
Glycocalyx levels
pancreatectomy
human albumin 5%
gelofusine
pancreatic fistula
Additional relevant MeSH terms:
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Pancreatic Fistula
Fistula
Digestive System Diseases
Pancreatic Diseases
Pathological Conditions, Anatomical
Digestive System Fistula
Polygeline
Plasma Substitutes
Blood Substitutes