Glycocalyx Levels in Patients Undergoing Pancreatectomy With Human Albumin 5% vs. Gelofusine
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in serum heparan sulfate concentrations
研究概览
简要总结
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.
详细描述
This is a prospective study that will be conducted in the Main Operating theatres of UMMC on patients with pancreatic cancer undergoing elective pancreatectomy (includes all forms of pancreatectomy such as Whipple's procedure, total or distal pancreatectomy).
This study aim to determine the association of glycocalyx degradation by measuring levels of syndecan-1 and heparan sulfate with type of colloidal fluid given, human albumin 5% versus gelofusine in a restrictive goal directed fluid therapy in pancreatectomy.
Institutional ethics approval and registration in Clinical Trial Registry will be obtained before recruiting the first case.
Recruited patients will be randomly allocated to either the group receiving human albumin 5% or gelofusine.
Sample size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 18-75 years old with written informed consent
排除标准
- •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),
- •Allergic to gelofusine and human albumin
结局指标
主要结局
Changes in serum heparan sulfate concentrations
时间窗: Within post-op 7 days
Blood samples are collected to check for heparan sulfate concentrations in serum
Occurence of pancreatic fistula leak
时间窗: Within post-op 30 days
Review will be done according to guideline of Revised 2016 International Study Group on Pancreatic Fistula (ISGPF)
Changes in serum syndecan 1 concentrations
时间窗: Within post-op 7 days
Blood samples are collected to check for syndecan 1 concentrations in serum
次要结局
- Changes in levels of Inflammatory markers Interleukin-1 and CRP(Within post-op 7 days)
研究者
Dr Loh Pui San
Consultant Anaesthesiologist
University of Malaya