NCT02998346

Brief Summary

The purpose of this observational study is to measure the number of calories delivered from fluids used in continuous renal replacement therapy (CRRT). We are doing this research study because the fluids used in this treatment may deliver an important number of calories. In the future this could help better estimate how much nutrition patients in the Critical Care Unit should get every day from other sources like tube feeding or nutrition through a person's veins.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2017

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

December 16, 2016

Last Update Submit

January 29, 2018

Conditions

Acute Kidney Injury

Keywords

NutritionCRRTCVVHcitrateanticoagulationcaloric uptake

Outcome Measures

Primary Outcomes (2)

  • Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration

    Two days

  • Quantify net citrate uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration

    Two days

Eligibility Criteria

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

Critically ill patients initiated on continuous venovenous hemofiltration receiving regional citrate anticoagulation with ACD-A solution.

You may qualify if:

  • Age greater than or equal to 18 years
  • Patients in an intensive care unit anticipated to receive greater than or equal to 24 hours of continuous venovenous hemofiltration.
  • Receiving regional citrate anticoagulation with ACD-A solution.

You may not qualify if:

  • Vulnerable adults
  • Pregnant
  • BMI \> 40
  • Patient on extracorporeal membrane oxygenation therapy
  • Reversal of port connections on the dialysis catheter and dialysis circuit lines

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pharmacy

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 20, 2016

Study Start

April 1, 2014

Primary Completion

June 28, 2017

Study Completion

June 28, 2017

Last Updated

January 31, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share