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临床试验/NCT07221630
NCT07221630尚未招募不适用

Effects of Conventional and Dilutional Ultrafiltration Techniques During Cardiopulmonary Bypass in Pediatric Cardiac Patients

Akron Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
C-Reactive Protein outcome measure concentration in mg/dL

研究概览

简要总结

The investigators will be comparing two different filtration methods on cardiopulmonary bypass for pediatric heart surgery patients. Three blood tests will be taken from the patient to compare which filtration method is better at decreasing post-cardiopulmonary bypass inflammation caused by the heart-lung machine.

详细描述

The study holds promise to evaluate the efficacy of dilutional ultrafiltration (DUF) compared to the currently utilized conventional ultrafiltration method in a prospective randomized controlled trial. A disposable hemoconcentrator is included in the cardiopulmonary bypass circuit which allows for removal of plasma water and solutes with a molecular weight below 65,000 Daltons. Alternatively, dilutional ultrafiltration (DUF) is a process during cardiopulmonary bypass that uses a hemoconcentrator to remove effluent containing inflammatory mediators but also return equal amounts of Plasmalyte to the patient's blood volume through the cardiopulmonary bypass circuit. Plasmalyte is a balanced crystalloid solution that has a similar concentration of electrolytes, osmolality, and pH to human plasma. The "dilutional effect" in DUF is caused by adding Plasmalyte and reducing inflammatory mediators in a patient's entire blood volume while also replacing necessary electrolytes lost during ultrafiltration. The purpose of this study is to examine plasma C-Reactive Protein levels pre-bypass, 12 hours post-bypass, and 24 hours post-bypass comparing the two filtration methods to discover if there is a measurable decrease in postoperative inflammation using dilutional ultrafiltration (DUF) compared to conventional ultrafiltration (CUF). The primary objective of this trial is to evaluate the efficacy of dilutional ultrafiltration (DUF) compared to conventional ultrafiltration (CUF) on cardiopulmonary bypass patients by measuring the outcome of C-Reactive Protein (CRP). The secondary objective is to track postoperative clinical measurements associated with inflammation such as postoperative fluid balance, alveolar arterial gradient, inotrope score, diuretic need, time to negative fluid balance, postoperative length of intubation, and length of ICU stay.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Males and females less than 5 years of age
  • Cardiac operations utilizing CPB
  • Cardiac reoperations utilizing CPB

排除标准

  • Patients greater than 5 years of age.
  • Any active SYSTEMIC noncardiac disease expected to raise patient baseline CRP levels to above normal levels (>1mg/dL). Since CRP levels correlate with the severity of most skin disease, patients with active dermatitis issues on the day of surgery will be excluded from the study. Patients with autoimmune diseases including RA, SLE, IBD (Crohn's disease, ulcerative colitis), Kawasaki disease and patients experiencing active infections will be excluded from the study.
  • Any noncardiac disease not well controlled (ex. Asthma not properly controlled with medication, etc.)
  • Recent viral illness (ex. Positive COVID/flu test 30 days prior to surgery)
  • All patients receive solumedrol (10mg/kg dose) from anesthesia as part of the prebypass protocol. Any patient currently taking steroids will also be excluded from the study
  • Non-cardiopulmonary bypass cases (Off pump CoA, Vascular ring surgery, etc.)
  • ECMO patients
  • Emergent cases

结局指标

主要结局

C-Reactive Protein outcome measure concentration in mg/dL

时间窗: Baseline measurement

Measure of acute inflammation in the body

C-Reactive Protein concentration in mg/dL

时间窗: 12 hours post-bypass

Measure of acute inflammation in the body

C-Reactive Protein concentration measured in mg/dL

时间窗: 24 hours post-bypass

Measure of acute inflammation in the body

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindsey Stuhm

Certified Clinical Perfusionist

Akron Children's Hospital

研究点 (1)

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