NCT02470520

Brief Summary

The aim of this study is to measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI. In patients who are treated with continuous renal replacement therapy, we plan to evaluate whether there are any additional losses of nutrients into the filtrate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

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

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

June 10, 2015

Last Update Submit

May 16, 2016

Conditions

Acute Kidney Failure

Outcome Measures

Primary Outcomes (1)

  • serum levels of essential nutrients

    up to 6 days

Secondary Outcomes (1)

  • levels of essential nutrients in filtrate

    up to 6 days

Study Arms (2)

AKI without CRRT

Patients with AKI who are not treated with continuous renal replacement therapy

AKI with CRRT

Patients with AKI who are treated with continuous renal replacement therapy

Procedure: CRRT

Interventions

CRRTPROCEDURE

continuous renal replacement therapy

AKI with CRRT

Eligibility Criteria

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

Critically ill patients with severe acute kidney injury

You may qualify if:

  • adult patients in the Critical Care Unit with severe AKI

You may not qualify if:

  • pre-existing dialysis dependent renal failure
  • life expectancy \<48 hours
  • need for total parenteral nutrition
  • need for supplementation with intravenous multivitamins or trace elements
  • Jehovah's witness
  • patients with haemoglobin \<7g/dL (unless being transfused for clinical reasons)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05