Clinical trial NCT04962516: Evaluation of the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion
Official title: Open, Randomized, Parallel Controlled Clinical Trial to Evaluate the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single-use Precision Filter Infusion Set
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
First posted: 2021-07-15
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE

Brief summary: This study is a pre-market clinical trial of a single-use precision filter infusion set for pumps, to evaluate the safety and effectiveness of a single-use precision filter infusion set for pumps after being used in humans, and to provide clinical evidence for the official application of the product in China

Detailed description: This experiment compares the single-use precision filter infusion set produced by Shandong Xinhua Ande Medical Products Co., Ltd. for the same intended use that has been approved to market, and compares the performance of the two products in clinical use, the overall pass rate, and the occurrence of phlebitis Rates and adverse events are used to evaluate the safety and effectiveness of single-use precision filtration infusion sets for pumps.

Eligibility criteria: Inclusion Criteria:

1. age 18 years or older, gender not limited;
2. intravenous infusion requiring drug filtration, flow regulation, dosing and extension of infusion line;
3. not participating in other clinical trials within one month;
4. able to understand the purpose of the trial, voluntarily participate and sign the informed consent;
5. willing to follow up and evaluate according to the requirements of the trial protocol.

Exclusion Criteria:

1. Patients with positive pregnancy test in women of childbearing age or lactating women;
2. Patients with uncontrollable cardiomyopathy, heart failure and unable to tolerate infusion;
3. Patients with uncontrollable decompensated renal function, especially in the anuric phase of acute renal failure and unable to tolerate infusion;
4. Patients with uncontrollable extensive inflammation of the lung parenchyma, pulmonary congestion, pulmonary edema and unable to tolerate infusion;
5. 0.2um size Test devices combined with any of the following drugs or preparations: fatty milk type, blood products type (blood cells, globulin, etc.), drugs that will produce insoluble precipitates with each other, etc.; 6, patients who are clinically infused with very small amounts of drugs (due to residual test line may reduce the amount of drugs delivered to patients); 7, puncture sites with inflammation, tumors, trauma, scars, etc.; 8, those who may be allergic to product materials; 9 Patients with AIDS;

10. Patients with mental disorders; 11. Other patients who are considered by the investigator to be unsuitable for participation in this study

Primary outcomes:
measure: Vital signs
timeFrame: 2 hr after injection
measure: Vital signs
timeFrame: 24 hr after injection
measure: adverse events and complications
timeFrame: 2 hr after injection
measure: adverse events and complications
timeFrame: 24 hr after injection
measure: number of heat source reactions
timeFrame: 2 hr after injection
measure: number of heat source reactions
timeFrame: 24 hr after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Baohua Li
role: PRINCIPAL_INVESTIGATOR
References: