Safety of Norepinephrine Administered Through Peripheral Venous Catheter

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Christer Svensen，Karolinska Institutet

Tracking Information

First Submitted Date ^ICMJE

September 14, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

May 29, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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)

Descriptive Information

Brief Title ^ICMJE

Safety of Norepinephrine Administered Through Peripheral Venous Catheter

Official Title ^ICMJE

A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Drug: Peripheral administration of Norepinephrine
Systematic follow-up of complications from peripheral administration of Norepinephrine

Study Arms

: Peripheral Norepinephrine
Patients who will undergo surgery with need for vasopressor support.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 1, 2020

Estimated Primary Completion Date

May 29, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Sweden

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Christer Svensen，Karolinska Institutet

Study Sponsor ^ICMJE

Christer Svensen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Elisabeth Andersson, MD Stockholm South General Hospital

PRS Account

Karolinska Institutet

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名