A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,004
- 试验地点
- 3
- 主要终点
- Proportion of patients with treatment-related adverse events
研究概览
简要总结
Norepinephrine is a drug that elevates the blood pressure. It is routinely administered through peripheral catheters during surgery. There is a risk of tissue damage in case of leakage of Norepinephrine from the catheter to the surrounding tissue. Another risk is irregular administration of Norepinephrine due to kinking of the peripheral catheter. This could lead to fluctuations in blood pressure. The primary aim of the study is to investigate complications from Norepinephrine administered in peripheral venous catheters. The secondary aim is to investigate if comorbidity, placement of the peripheral catheter or the duration of the infusion are associated with a higher rate of complications. 1000 patients will be included. Inclusion criteria: Patients who will undergo surgery with need for vasopressor support. Exclusion criteria: The patient has a central venous catheter, a peripherally inserted central venous catheter or lack of informed consent.
详细描述
In many hospitals in Sweden, Norepinephrine is administered through peripheral venous catheters in the operating room. However there are very few studies to support the safety of peripherally administered Norepinephrine.
Norepinephrine of the concentration 8 respectively 40 microg/ml will be investigated. The primary aim of the study is to investigate complications from Norepinephrine administered in peripheral venous catheters. The secondary aim is to investigate if comorbidity, placement of the peripheral catheter or the duration of the infusion are associated with a higher rate of complications.
The localisation and size of the peripheral venous catheter will be registered. The blood pressure will me measured every 5 minutes and every minute in case of systolic blood pressure over 220 mm Hg.
The site of administration will regularly be monitored for complications. If subcutaneous infusion of Norepinephrine is suspected, the patient will be followed up for up to 48 hours or until hospital discharge.
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
- •Patient who has general anesthesia or central blocks
- •Need for vasopressors in the pre, per or postoperative period to maintain adequate mean arterial blood pressure
- •Age ≥18 years
排除标准
- •The patient has a central venous line
- •The patient has a peripherally inserted central line
- •Lack of informed consent
研究组 & 干预措施
Peripheral Norepinephrine
Patients who will undergo surgery with need for vasopressor support.
干预措施: Peripheral administration of Norepinephrine (Drug)
结局指标
主要结局
Proportion of patients with treatment-related adverse events
时间窗: 0-72 hours
Proportion of patients with complications (Subcutaneous infusion and/or hypertension\>220 mmHg and/or heart rate\<40 beats/min)
次要结局
- Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications(0-72 hours)
研究者
Christer Svensen
Professor
Karolinska Institutet