NCT00780351

Brief Summary

  1. 1.Sustained low efficiency daily hemodiafiltration(SLEDD-f) is a kind of renal replacement therapy with high-flux dialyser membrane (helixone).
  2. 2.The pore size of helixone is larger than most antibiotics, and vancomycin is supposed to be removed during dialysis.
  3. 3.Our study wants to find the amount of vancomycin removed during SLEDD-f, and try to find the most appropriate dose regimen for this kind of patients.

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 Oct 2008

Shorter than P25 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

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 23, 2009

Status Verified

October 1, 2009

First QC Date

March 5, 2008

Last Update Submit

October 21, 2009

Conditions

Acute Renal Failure

Keywords

vancomycin, SLEDD-f

Outcome Measures

Primary Outcomes (2)

  • The amount of vancomycin removed during one course of SLEDD-f

    8 hr (during one course of SLEDD-f)

  • The pharmacokinetics and dosing regimen of vancomycin in patients on SLEDD-f.

    26 hr

Study Arms (1)

SLEDD-f, vanco

Surgical ICU patients who is on slow low efficiency daily hemodiafiltration (SLEDD-f) and requires vancomycin therapy

Device: sustained low efficiency daily hemodiafiltration (SLEDD-f)

Interventions

sustained low efficiency daily hemodiafiltration (SLEDD-f)DEVICE

vancomycin 15mg/kg IV infusion on day 1 from 6PM to 8PM. Start SLEDD-f on day 2 from 9AM to 5PM.

SLEDD-f, vanco

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in intensive care unit.

You may qualify if:

  • Acute renal failure of any cause
  • Use SLEDD-f as renal replacement therapy
  • Priscribe vancomycin for a known or suspected infection

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Fe-Lin L Wu, MSCP, Ph.D.

    School of pharmacy, Graduate institute of clinical pharmacy, Department of Pharmacy of National Taiwan University Hospital, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

  • Wen-Je Ko, MD, PhD

    Department of Surgery, National Taiwan University Hospital, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2008

First Posted

October 27, 2008

Study Start

October 1, 2008

Study Completion

August 1, 2009

Last Updated

October 23, 2009

Record last verified: 2009-10

Locations

TW(1)