Acute Kidney InjuryNCT02998346
Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT)
An observational study of Acute Kidney Injury, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to 28 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients initiated on continuous venovenous hemofiltration receiving regional citrate anticoagulation with ACD-A solution.
Who may be able to join
- 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.
Who cannot join
- Vulnerable adults
- Pregnant
- BMI > 40
- Patient on extracorporeal membrane oxygenation therapy
- Reversal of port connections on the dialysis catheter and dialysis circuit lines
About this study
Official title: Quantification of Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT) Utilizing Regional Citrate Anticoagulation
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.
Read the detailed description
The goal of this study is to quantify the specific metabolic contribution of standard continuous renal replacement protocols (including citrate anticoagulation) in the intensive care unit patient population at Mayo Clinic in Rochester, Minnesota utilizing a prospective, observational study. This data will allow practitioners to better tailor caloric provision with nutrition support programs, minimizing the risk of overfeeding in this complex critical care patient population.
- Conditions
- Acute Kidney Injury
- Keywords
- Nutrition, CRRT, CVVH, citrate, anticoagulation, caloric uptake
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
Measured: Two days
Quantify net citrate uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startApr 2014
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Nystrom, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998346
- Sponsor's protocol ID
- 13-009155
- Status last verified
- Jan 2018
- First submitted
- 16 Dec 2016
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT) Utilizing Regional Citrate Anticoagulation
- ClinicalTrials.gov ID
- NCT02998346
- Acronym / sponsor ID
- 13-009155
- Conditions
- Acute Kidney Injury
- Keywords
- Nutrition, CRRT, CVVH, citrate, anticoagulation, caloric uptake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to quantify the specific metabolic contribution of standard continuous renal replacement protocols (including citrate anticoagulation) in the intensive care unit patient population at Mayo Clinic in Rochester, Minnesota utilizing a prospective, observational study. This data will allow practitioners to better tailor caloric provision with nutrition support programs, minimizing the risk of overfeeding in this complex critical care patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients initiated on continuous venovenous hemofiltration receiving regional citrate anticoagulation with ACD-A solution.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Vulnerable adults
- Pregnant
- BMI > 40
- Patient on extracorporeal membrane oxygenation therapy
- Reversal of port connections on the dialysis catheter and dialysis circuit lines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
Time frame: Two days
Quantify net citrate uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration
Time frame: Two days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration (time frame: Two days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.