Safety of Norepinephrine Administered Through Peripheral Venous Catheter
追踪信息 | |||
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首次提交日期 ICMJE | September 14, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | October 1, 2018 | ||
预计主要完成日期 | May 29, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Proportion of patients with treatment-related adverse events[ Time Frame: 0-72 hours ] Proportion of patients with complications (Subcutaneous infusion and/or hypertension>220 mmHg and/or heart rate<40 beats/min) |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Safety of Norepinephrine Administered Through Peripheral Venous Catheter | ||
正式标题 ICMJE | A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery | ||
简要概况 | 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. |
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详细说明 | 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. | ||
研究类型 ICMJE | Observational | ||
研究阶段 | |||
研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
1000 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | June 1, 2020 | ||
预计主要完成日期 | May 29, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - 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 Exclusion Criteria: - The patient has a central venous line - The patient has a peripherally inserted central line - Lack of informed consent | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Sweden | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Christer Svensen,Karolinska Institutet | ||
研究赞助商 ICMJE | Christer Svensen | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Karolinska Institutet | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |