Kidney Injury, AcuteNCT01824771
Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients
An observational study of Kidney Injury, Acute, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Injury, Acute
- What is being tested?
- Plasma lactate were measured
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2013to 20 Mar 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- APACHE II scores lower than 12
- patients' age are more than 75Y or lower than 18Y
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
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.
- Conditions
- Kidney Injury, Acute
- Being tested
- Plasma lactate were measured
- Keywords
- Continuous veno-venoous haemofiltration, Plasma lactate, Critical illness, Acute kidney injurytissue perfusion, Multiple organ dysfunction syndrome
- Medical subject headings
- Acute Kidney Injury, Critical Illness, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma lactate were measuredOther
Three different doses (20 ml/kg/h, 35 ml/kg/h and 45 ml/kg/h) of CVVH were applied to critically ill patients who experiencing CVVH. Each dose of CVVH was sequentially gave to each patient and lasted for 30 minutes separately
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma lactate
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study start3 Mar 2013
- Primary completion3 Mar 2015
- Study completion20 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Injury, AcuteStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yong-Jun, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824771
- Sponsor's protocol ID
- 2013232
- Status last verified
- Jul 2022
- First submitted
- 28 Mar 2013
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levraut J, Ciebiera JP, Jambou P, Ichai C, Labib Y, Grimaud D. Effect of continuous venovenous hemofiltration with dialysis on lactate clearance in critically ill patients. Crit Care Med. 1997 Jan;25(1):58-62. doi: 10.1097/00003246-199701000-00013.
PubMed 8989177
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01824771
- Acronym / sponsor ID
- 2013232
- Conditions
- Kidney Injury, Acute
- Keywords
- Continuous veno-venoous haemofiltration, Plasma lactate, Critical illness, Acute kidney injurytissue perfusion, Multiple organ dysfunction syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 3 Mar 2013 (actual)
- Primary completion
- 3 Mar 2015 (actual)
- Study completion
- 20 Mar 2015 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- APACHE II scores lower than 12
- patients' age are more than 75Y or lower than 18Y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma lactate were measuredThree different doses (20 ml/kg/h, 35 ml/kg/h and 45 ml/kg/h) of CVVH were applied to critically ill patients who experiencing CVVH. Each dose of CVVH was sequentially gave to each patient and lasted for 30 minutes separately | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Results publication: PubMed 8989177Levraut J, Ciebiera JP, Jambou P, Ichai C, Labib Y, Grimaud D. Effect of continuous venovenous hemofiltration with dialysis on lactate clearance in critically ill patients. Crit Care Med. 1997 Jan;25(1):58-62. doi: 10.1097/00003246-199701000-00013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, Acute, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma lactate (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01824771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.