Acute Renal FailureNCT01946113
Mineral-Homeostasis in Continuous Renal Replacement Therapy
An observational study of Acute Renal Failure, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Acute renal failure is a common complication in intensive care unit patients. In 10% of cases renal replacement therapy becomes necessary. Current devices have increase filter patency and efficacy. However, magnesium, calcium and phosphate are eliminated as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Aug 2015
- 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: intensive care unit patients with acute renal failure undergoing renal replacement therapy
Who may be able to join
- intensive care unit patients with acute renal failure undergoing continuous renal replacement therapy
- older than 18 years of age
Who cannot join
- age less than 18 years
- pregnancy
- contraindications against continuous renal replacement therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Interdisziplinäre Intensivstation Universitätsklinikum Düsseldorf
Düsseldorf, 40225
About this study
Official title: Phosphate, Magnesium and Calcium-Homeostasis in Patients With Acute Renal Failure and Continuous Renal Replacement Therapy
Acute renal failure is a common complication in intensive care unit patients. In 10% of cases renal replacement therapy becomes necessary. Current devices have increase filter patency and efficacy. However, magnesium, calcium and phosphate are eliminated as well. However, the extend of this elimination hase not been quantified. Thus, we want to
- record retrospectively how often abnormal values for phosphate, magnesium and calcium occurred during routine renal replacement therapy in 2011 and 2012.
- prospectively evaluate the same parameters during routine treatment in 2013 and 2014
- Conditions
- Acute Renal Failure
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospektive Cohort | Patients requiring renal replacement therapy from 2011 to 2012 on intensive care unit | |
| Prospektive Cohort | Patients requiring renal replacement on intensive care unit in 2013 and 2014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypo-phosphate,-magnesium and calcaemia
Participants will be followed for the duration of ICU stay, an expected average of 28 days
Measured: approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Detlef Kindgen-Milles, Prof., Principal investigator, Department of Anaesthesiology, Duesseldorf University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946113
- Sponsor's protocol ID
- 4209
- Status last verified
- Aug 2015
- First submitted
- 9 Sep 2013
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphate, Magnesium and Calcium-Homeostasis in Patients With Acute Renal Failure and Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01946113
- Acronym / sponsor ID
- 4209
- Conditions
- Acute Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Sep 2013 (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.
Acute renal failure is a common complication in intensive care unit patients. In 10% of cases renal replacement therapy becomes necessary. Current devices have increase filter patency and efficacy. However, magnesium, calcium and phosphate are eliminated as well. However, the extend of this elimination hase not been quantified. Thus, we want to
- record retrospectively how often abnormal values for phosphate, magnesium and calcium occurred during routine renal replacement therapy in 2011 and 2012.
- prospectively evaluate the same parameters during routine treatment in 2013 and 2014
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospektive Cohort | – | –Patients requiring renal replacement therapy from 2011 to 2012 on intensive care unit |
| Prospektive Cohort | – | –Patients requiring renal replacement on intensive care unit in 2013 and 2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care unit patients with acute renal failure undergoing renal replacement therapy
Key inclusion criteria (2 listed)
- intensive care unit patients with acute renal failure undergoing continuous renal replacement therapy
- older than 18 years of age
Key exclusion criteria (3 listed)
- age less than 18 years
- pregnancy
- contraindications against continuous renal replacement therapy
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
Incidence of hypo-phosphate,-magnesium and calcaemia
Time frame: approximately 28 days
Participants will be followed for the duration of ICU stay, an expected average of 28 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 20 Aug 2015.
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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.
Detlef Kindgen-Milles, Prof. principal investigator
Department of Anaesthesiology, Duesseldorf University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 2 inclusion and 3 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence of hypo-phosphate,-magnesium and calcaemia (time frame: approximately 28 days). 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 20 Aug 2015.