Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients

Sepsis Clinical Trial

— ETERNITY  

Official title:

Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03438214
• Other study ID #: 81226617.8.1001.0065
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 5, 2018
• Last updated: April 3, 2018
• Start date: April 28, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2018
• Source: University of Sao Paulo
• Contact: Juliano P Almeida, professor
• Phone: (5511)98149-2592
• Email: doctorjuliano[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled multicenter clinical trial. The purpose of this study is to compare the continuous infusion of vancomycin with intermittent infusion regarding the effectiveness to reach the target serum level and the relationship between infusion type and nephrotoxicity in critically ill patients.

Description:

The vancomycin is a glycopeptide antimicrobial which has been used for 50 years against gram-positive microorganisms and remains effective against multiresistant bacteria as the methicillin resistant Staphylococcus aureus (MRSA), the main microorganism causing nosocomial infections. Around the world, the continuous infusion of vancomycin has been studied and associated with less rate of nephrotoxicity. This is a randomized, controlled multicenter clinical trial that will compare continuous infusion with the intermittent vancomycin infusion, the relationship between infusion type with rate of nephrotoxicity and the time to target therapeutic serum in critically ill patients at the intensive care units of the Cancer Institute of the State of Sao Paulo (ICESP) and the Heart Institute (Incor).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 222
• Est. completion date: December 1, 2022
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Critically ill patients

• Treatment with vancomycin

• Preserved renal function.

Exclusion Criteria:

• Cystic fibrosis

• Chronic renal failure

• Acute renal failure

• Having received vancomycin in the last 24 hours

• Vancomycin hypersensibility

Related Conditions & MeSH terms

• Bacterial Infections
• Critical Illness
• Gram-Positive Bacterial Infections
• Nephrotoxicity
• Renal Insufficiency
• Sepsis

Intervention

Drug:
• Vancomycin Continuous infusion
Will be administered a loading dose of 25mg/kg followed of 2g infused in 24h. Serum levels will be measured after the end of the loading dose (peak) and after 24 hours (steady state). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and area under curve (AUC) /MIC=400mg.h/L
• Vancomycin Intermittent infusion
Will be administered a loading dose of 25mg/kg followed of 1g every 12h. Serum levels will be measured after the end of the loading dose (peak) and one hour before the next dose (trough). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and AUC/MIC=400mg.h/L.

Locations

Country	Name	City	State
Brazil	Faculty of Medicine University os São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute renal failure	Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).	30 days after randomization
Secondary	Acute renal failure	Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).	30 days after randomization
Secondary	Hypersensibility reactions with vancomycin	Skin rash, bronchospasm or anaphylaxis / anaphylactic shock.	30 days after randomization
Secondary	Length of ICU stay	Therapeutic efficacy with less length of ICU stay	30 days after randomization
Secondary	Time of treatment with the antimicrobial	Therapeutic efficacy with less time of treatment with the antimicrobial	30 days after randomization
Secondary	Length of hospitalization	Therapeutic efficacy with less length of hospitalization	30 days after randomization
Secondary	Mortality rate	Therapeutic efficacy with less mortality rate	30 days after randomization