Renin as a Biomarker of Haemodynamic Normalisation: Associations With Outcomes After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Patterns of changes in serum renin concentrations are associated with composite morbidity at 30 days in participants who have undergone cardiac surgery.
研究概览
简要总结
Study design Observational, single centre, prospective cohort study Planned sample size 100 participants
Inclusion criteria The study will evaluate a cohort of participants meeting the following inclusion criteria:
- admission to the Intensive Care Unit (ICU) after elective and emergency cardiac surgery using cardiopulmonary bypass
- age 18 years and above
- arterial, central venous and pulmonary arterial catheters have been inserted as part of routine care Study procedures In addition to routine clinical postoperative data and blood collection, serum renin levels will be analysed on admission, 6 and 24 hours after admission to ICU Study duration 6 months
详细描述
The renin-angiotensin aldosterone system (RAAS) is integral to cardiovascular homeostasis and involved in the regulation of blood pressure, electrolyte balance and intravascular volume. Renin is produced from the renal juxtaglomerular cells and converts angiotensinogen to angiotensin. Angiotensin is subsequently converted to angiotensin II by angiotensin-converting enzyme (ACE). Angiotensin II also promotes the release of aldosterone.The RAAS has an important role in hypotension to retain water through aldosterone and increase systemic vascular resistance mainly through angiotensin II but also through the release of vasopressin.
The RAAS can become dysregulated in critically ill shocked patients. In states such as septic shock the effects of the RAAS are antagonized through the production of vasodilators such a nitric oxide and both angiotensin I and angiotensin II receptors are down regulated. Activation of angiotensin I receptors may furthermore result in the production of pro-inflammatory cytokines that results in further vasodilation and contributes to cardiovascular compromise.
While the RAAS has been extensively investigated in cardiovascular patients there is a paucity of studies relevant to ICU. A recent study suggested that raised serum renin levels in patients with sepsis is associated with acute renal failure. Another study of a small heterogeneous cohort of critically ill patients compared renin to lactate as marker of tissue perfusion.
As RAAS is closely related to the volume state, there is a physiological rationale to investigate serum renin levels together with variables to monitor the intravascular volume, including assessment of the mean systemic filling pressure (Pmsf). An analogue of the Pmsf will be calculated in this study based on routine postoperative haemodynamic monitoring (mean arterial pressure, MAP, central venous pressure, CVP, cardiac output, CO).
Furthermore, there is no current research which looks at serum renin as marker of hemodynamic normalization or association with outcomes after cardiac surgery which is the main purpose of this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to ICU after elective and emergency cardiac surgery following cardiopulmonary bypass
- •Age 18 years and above
- •Arterial, central venous catheters and pulmonary arterial catheters are inserted preoperatively
排除标准
- •Age under 18 years
- •Known pregnancy
- •Arterial, central venous catheters and pulmonary arterial catheters that are not indicated as part of routine care
- •End stage renal disease requiring renal replacement therapy
- •Participants with known Child Pugh A cirrhosis or greater
- •Treatment with any steroids
- •Participant is not expected to live beyond the day after the day of admission
结局指标
主要结局
Patterns of changes in serum renin concentrations are associated with composite morbidity at 30 days in participants who have undergone cardiac surgery.
时间窗: 30 days
次要结局
- Patterns of changes in serum renin concentrations correlate with current markers of resuscitation in participants who have undergone cardiac surgery ( C.I, SvO2, MAP, urine output, serum lactate, based deficit, venoarterial CO2 gradients)(24 hours)
- Serum renin concentrations correlate with Pmsa in postoperative cardiac surgical patients(24 hours)
- Patterns of changes in serum renin concentrations are associated with AKI or the need for CRRT in participants who have undergone cardiac surgery(30 days)
研究者
Anders Aneman
Professor
South West Sydney Local Health District