健康去哪儿
健趣网登录 关闭
还没有账号?立即注册

Safety of Norepinephrine Administered Through Peripheral Venous Catheter

赞助:
合作者:
信息的提供 (责任方):
Christer Svensen,Karolinska Institutet
September 14, 2018
October 4, 2018
October 4, 2018
October 1, 2018
May 29, 2020   (主要结果测量的最终数据收集日期)
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)

与当前相同
  • Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications[ Time Frame: 0-72 hours ]
    Odds ratio of Treatment-Emergent Adverse Events in risk groups (ASA>2, placement of catheter distal to the antecubital or popliteal fossae, duration of infusion> 4 hours)
 
Safety of Norepinephrine Administered Through Peripheral Venous Catheter
A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery

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.

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.
Observational
分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:
  • Drug: Peripheral administration of Norepinephrine
    Systematic follow-up of complications from peripheral administration of Norepinephrine
  • : Peripheral Norepinephrine
    Patients who will undergo surgery with need for vasopressor support.
 
Not yet recruiting
1000
与当前相同
June 1, 2020
May 29, 2020   (主要结果测量的最终数据收集日期)
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
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
Sweden
 
No
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
计划分享 IPD: No
Christer Svensen,Karolinska Institutet
Christer Svensen
Principal Investigator: Elisabeth Andersson, MD Stockholm South General Hospital
Karolinska Institutet
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
请使用微信扫码报名