NCT01824771

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2015

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2015

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

March 28, 2013

Last Update Submit

July 25, 2022

Conditions

Keywords

Continuous veno-venoous haemofiltrationPlasma lactateCritical illnessAcute kidney injurytissue perfusionMultiple organ dysfunction syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    30 minutes

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • APACHE II scores lower than 12
  • patients' age are more than 75Y or lower than 18Y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney InjuryCritical IllnessMultiple Organ Failure

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 5, 2013

Study Start

March 3, 2013

Primary Completion

March 3, 2015

Study Completion

March 20, 2015

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations