NCT00816790

Brief Summary

The objective of this study is to determine the feasibility of conducting a large scale randomized controlled trial comparing standard and renally adjusted dosage of antibiotics in the septic shock patients with acute renal dysfunction. We will use Piperacillin as the prototype antibiotic in our study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

December 31, 2008

Last Update Submit

September 10, 2015

Conditions

Septic ShockAcute Renal Failure

Keywords

Septic shockAcute Renal FailureAntimicrobialDrug DosingFeasibility Study

Outcome Measures

Primary Outcomes (1)

  • To determine rate of patient accrual (ability to identify and enrol patients in a timely fashion) and protocol adherence for this pilot randomized controlled trial.

    4 months

Secondary Outcomes (1)

  • ICU and hospital mortality. ICU and hospital length of stay. Duration of mechanical ventilation.

    1 months

Study Arms (2)

Dose Adjusted

ACTIVE COMPARATOR

This arm will receive their broad spectrum antibiotic as an adjusted dose based on their renal function as measured when sepsis is diagnosed and antimicrobials are initiated

Drug: Piperacillin/Tazobactam

Unadjusted Dose

EXPERIMENTAL

This arm will receive their broad spectrum antibiotic as an unadjusted dose regardless of their renal function

Drug: Piperacillin/Tazobactam

Interventions

Piperacillin/TazobactamDRUG

eGFR 20-40 mls/min: Piperacillin/Tazobactam 3.375g IV q6h x 24 hours eGFR \< 20 mls/min: Piperacillin/Tazobactam 2.25g IV q6h x 24 hours

Also known as: Tazocin
Dose Adjusted

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with septic shock according to the Surviving Sepsis Campaign
  • Age \> 19
  • Most recent eGFR\<40 mls/min

You may not qualify if:

  • Pregnant
  • Known chronic renal failure patients who are dialysis dependant
  • Administration of systemic antibiotics \> 1 dose
  • Not expected to survive 28 days due to an underlying medical illness
  • Allergy to Piperacillin/Tazobactam or any components of formulation within

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

MeSH Terms

Conditions

Shock, SepticAcute Kidney Injury

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Sean Keenan, MD

    Fraser Health Authority

    PRINCIPAL INVESTIGATOR

  • Matthew Wiens, BSc PharmD

    Fraser Health Authority

    STUDY DIRECTOR

  • Vincent Mabasa, BSc PharmD

    Fraser Health Authority

    STUDY DIRECTOR

  • Sanjiv Kangura, BSc

    Fraser Health Authority

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intensivist

Study Record Dates

First Submitted

December 31, 2008

First Posted

January 5, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

CA(1)