- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01824771
Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients
July 25, 2022 updated by: Liu Yong-Jun, First Affiliated Hospital, Sun Yat-Sen University
Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively and replace renal function partly.
It is widely used in intensive care units (ICUs), especially for patients with acute kidney injury/failure in an unstable hemodynamic status.
Lactate is a molecule smaller than glucose, which can pass through filtration membrane freely in CVVH.
Therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status in patients with unstable hemodynamic status.
However, there is no prospective study evaluated the effect of CVVH on lactate removal in critically ill patients.
The influence of different dose of CVVH on lactate elimination is not clear in patients with different level of serum lactate.
Our study aimed to find out how the dose of CVVH effects on lactate clearance, and then re-estimate the prognostic value of lactate in critically ill patients with CVVH.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- The First Affiliated Hospital, Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study was carried out in Surgical Intensive Care Unit (SICU) of the first affiliated hospital, Sun Yat-sen University.The project has been approved by Ethics Committee of Sun Yat-sen University.
All the subjects have signed written informed consent.
Description
Inclusion Criteria:
- The critical ill patients with acute kidney injury
- Patients requiring continuous veno-venous hemofiltration
- APACHE II scores more than 12
- Arterial lactate is higher than 0.5mmol/L but lower than 15mmol/L (due to the sensitivity and optimal measuring range of the equipment)
- Continuous veno-venous hemofiltration for at least 12 hrs
- Hemo-filter age of <24 hrs
Exclusion Criteria:
- APACHE II scores lower than 12
- patients' age are more than 75Y or lower than 18Y
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plasma lactate
Time Frame: 30 minutes
|
Each dose of CVVH was lasted for 30 minutes separately.
Blood samples were draw pre-(A) and post-dialyzer (V) site after each dosage of CVVH was carried out for 30 minutes and then plasma lactates were measured immediately
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2013
Primary Completion (Actual)
March 3, 2015
Study Completion (Actual)
March 20, 2015
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
April 2, 2013
First Posted (Estimate)
April 5, 2013
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013232
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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