NCT06487585招募中4 期
Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery (ANG-First Trial)
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of postoperative acute kidney injury, atrial fibrillation
研究概览
简要总结
The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients ≥ 18 years of age undergoing cardiac surgery requiring CPB
- •Patients must have clinical features of vasodilation as determined by a MAP < 65 mmHg that is non-transient in the opinion of the treating physician
- •Patients must be adequately volume resuscitated in the opinion of the treating physician
- •Systemic Vascular Resistance index (SVRi) < 1970 dynes·sec/cm⁵/m² to support the clinical diagnosis of vasodilation; if no pulmonary artery catheter is in place, vasodilatory hypotension diagnosis according to the judgement of the critical care team
- •Biventricular systolic function is at or greater than pre-cardiopulmonary bypass baseline as demonstrated by echocardiographic evaluation, or the patient is concomitantly treated with
排除标准
- •Bleeding as primary etiology of hypotension, as determined by > 4 units RBC transfusion in 24 hours.
- •Patients on ECMO
- •Patients with active endocarditis
- •Patients already on renal replacement therapy or creatinine of > 4 mg/dl within 2 weeks of surgery
- •Patients with contraindications to Angiotensin II including women who are pregnant or breastfeeding or have active coronary ischemia, mesenteric ischemia, limb ischemia, or high potassium (> 5.5 meq/L) while receiving Angiotensin II
研究组 & 干预措施
Study Drug Arm - Angiotensin II arm
Other
Angiotensin II
干预措施: Angiotensin II (Drug)
结局指标
主要结局
Incidence of postoperative acute kidney injury, atrial fibrillation
时间窗: 28 days
The primary endpoint will be measured by comparing the incidence of new-onset atrial fibrillation or acute kidney injury
次要结局
- Hours on Vasopressors(28 days)
- Total IVF(28 days)
- ICU LOS(28 days)
- Postoperative LOS(28 days)
- Any major STS complication(28 days)
- 30-day mortality(30 days)
- Cost(28 days)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin IICardiac SurgeryVasoplegiaNCT06615102Universität Münster1,022
已完成
2 期
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By SurgeryBone CancerClear Cell Sarcoma of the KidneyMetastatic OsteosarcomaOvarian SarcomaRecurrent Adult Soft Tissue SarcomaRecurrent OsteosarcomaRecurrent Uterine SarcomaStage III Adult Soft Tissue SarcomaStage III Uterine SarcomaStage IV Adult Soft Tissue SarcomaStage IV Uterine SarcomaChondrosarcomaNCT01553539Wake Forest University Health Sciences20
终止
1 期
Contribution of Angiotensin II to Supine Hypertension in Autonomic FailurePure Autonomic FailureHypertensionMultiple System AtrophyNCT01292694Vanderbilt University12
已完成
1 期
Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot StudySeptic ShockNCT01393782George Washington University20
Unknown
2 期
Angiotensin in Septic Kidney Injury TrialAcute Renal FailureSepsisSeptic ShockNCT00711789Austin Health12