Complication of DialysisNCT01590550
Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
An observational study of Complication of Dialysis, run by Loma Linda University at 1 site in United States.
Trial summary
Providing hemodialysis requires the use of an extracorporeal circuit which must be anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased circuit blood flows, inefficient dialysis and even significant blood loss secondary to circuit clotting.Heparin has been traditional agent… Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Complication of Dialysis
- What is being tested?
- Use of citrate based dialysate
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Admitted pediatric patients
Who may be able to join
- All pediatric patients between the ages of 0-21 years in the inpatient setting requiring hemodialysis for renal replacement therapy. These will include both patients with chronic renal failure and acute kidney injury, or any patient requiring dialysis as determined by an attending nephrologist.
Who cannot join
- Symptomatic hypocalcemia that is refractory to treatment 24 hours prior to the start of each dialysis session
- Known liver disorder/acute liver failure with an inability to metabolize citrate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Children's Hospital
Loma Linda, California, 92350
About this study
Official title: A Prospective Study of Citrate Based Dialysate in Pediatric Patients Receiving Intermittent Hemodialysis
Providing hemodialysis requires the use of an extracorporeal circuit which must be anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased circuit blood flows, inefficient dialysis and even significant blood loss secondary to circuit clotting.Heparin has been traditional agent used to provide anticoagulation. Heparin has multiple adverse side effects that would be best avoided in acutely ill patients who are at risk for bleeding. Alternative means of providing anticoagulation include citrate based anticoagulation. Citrasate® is a heparin free anticoagulant alternative that has been FDA approved since 1999 and readily available for commercial use since 2001. Citrasate® utilizes citric acid instead of acetic acid for acidification; the presence of small amounts of citrate in the dialysate also provides the means for anticoagulation. The concentration of citrate is low (2.4meq/L) and thus has a minimal effect on serum calcium values. No calcium monitoring or infusion is indicated.
The purpose of this study is to obtain further data on the use of Citrasate® in admitted pediatric patients who receive hemodialysis as part of their therapy for acute kidney injury.
Read the detailed description
All patients requiring inpatient hemodialysis will be screened for participation in the study based on inclusion and exclusion criteria as noted above. Informed consent for hemodialysis and for study participation will be obtained by the attending nephrologist prior to the start of the dialysis session. Patient specific hemodialysis orders will be placed by attending nephrology physician for each patient using a standardized hemodialysis order form. Citrasate® in standard concentration, with a standard blood flow of 600 -800 ml/min will be prescribed for all study patients, calcium and potassium contents of the dialysate will be determined by the attending pediatric nephrologist.
Monitoring: All patients will have routine monitoring as indicated for clinical care during each dialysis session.
Data Collection:Each treatment will be documented on a standardized hemodialysis run sheet. Data collection will be performed by any one of the researchers using a data collection sheet to ensure uniformity of data collection methods. Data to be collected includes patient demographics, admitting diagnosis, underlying renal disease, the presence of acute kidney injury versus chronic kidney disease, contraindications to heparin use and the presence of any bleeding diathesis. Dialysis specific data to be collected will include the site and type of dialysis access, dialysis prescription parameters and treatment duration. Lab data to be collected will include pre, post and intradialytic ionized calcium values, ACT values and pH and bicarbonate values. Data on the number of saline boluses required to maintain circuit patency, percent of prescribed blood flow achieved as well as any use of heparin will be collected.
Data Analysis will include
- T-test for comparison of changes in ionized calcium values, blood pH and bicarbonate values
- Percentage of patients with inadequate coagulation on citrate (ie. patients with grade III-IV streaking or required changing to heparin based dialysate)
- Percent of patients with any adverse events not accounted for during an routine dialysis session
- Cost analysis for the difference in costs using Citrasate® compared to a standard heparin based dialysis treatment
- Conditions
- Complication of Dialysis
- Being tested
- Use of citrate based dialysate
- Keywords
- Pediatric hemodialysis, Anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of citrate based dialysateProcedure or surgery
Use of heparin free citrate based dialysate
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Single arm for all patient receiving inpatient HD Receives: Procedure: Use of citrate based dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialyzer Clotting Rate
Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.
Measured: Followed until HD with Citrate dialysate is discontinued, average 3 weeks
Secondary outcomes (2)
Saline Flush Rate
Saline flush rate will be assesed as the percentage of hemodialysis treatments that require one or more saline flushes to maintain circuit patency from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months
Measured: Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks
Heparin Use Rate
The heparin use rate will be assessed as the percentage of hemodialysis treatments that required additional use of heparin to maintain circuit patency. This will be assessed from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months
Measured: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complication of DialysisStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Sheth, Loma Linda University
- Investigators
- Rita D Sheth, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590550
- Sponsor's protocol ID
- 5120017
- Status last verified
- Oct 2020
- First submitted
- 29 Apr 2012
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Mean data will be presented
Publications
Hanevold C, Lu S, Yonekawa K. Utility of citrate dialysate in management of acute kidney injury in children. Hemodial Int. 2010 Oct;14 Suppl 1:S2-6. doi: 10.1111/j.1542-4758.2010.00483.x.
PubMed 21040414Davenport A. Anticoagulation options for pediatric hemodialysis. Hemodial Int. 2003 Apr 1;7(2):168-76. doi: 10.1046/j.1492-7535.2003.00022.x.
PubMed 19379358Cheng YL, Yu AW, Tsang KY, Shah DH, Kjellstrand CM, Wong SM, Lau WY, Hau LM, Ing TS. Anticoagulation during haemodialysis using a citrate-enriched dialysate: a feasibility study. Nephrol Dial Transplant. 2011 Feb;26(2):641-6. doi: 10.1093/ndt/gfq396. Epub 2010 Jul 8.
PubMed 20615906Gabutti L, Lucchini B, Marone C, Alberio L, Burnier M. Citrate- vs. acetate-based dialysate in bicarbonate haemodialysis: consequences on haemodynamics, coagulation, acid-base status, and electrolytes. BMC Nephrol. 2009 Mar 5;10:7. doi: 10.1186/1471-2369-10-7.
PubMed 19265544
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Citrate Based Dialysate in Pediatric Patients Receiving Intermittent Hemodialysis
- ClinicalTrials.gov ID
- NCT01590550
- Acronym / sponsor ID
- 5120017
- Conditions
- Complication of Dialysis
- Keywords
- Pediatric hemodialysis, Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Posted 1 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Providing hemodialysis requires the use of an extracorporeal circuit which must be anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased circuit blood flows, inefficient dialysis and even significant blood loss secondary to circuit clotting.Heparin has been traditional agent used to provide anticoagulation. Heparin has multiple adverse side effects that would be best avoided in acutely ill patients who are at risk for bleeding. Alternative means of providing anticoagulation include citrate based anticoagulation. Citrasate® is a heparin free anticoagulant alternative that has been FDA approved since 1999 and readily available for commercial use since 2001. Citrasate® utilizes citric acid instead of acetic acid for acidification; the presence of small amounts of citrate in the dialysate also provides the means for anticoagulation. The concentration of citrate is low (2.4meq/L) and thus has a minimal effect on serum calcium values. No calcium monitoring or infusion is indicated.
The purpose of this study is to obtain further data on the use of Citrasate® in admitted pediatric patients who receive hemodialysis as part of their therapy for acute kidney injury.
Detailed description
All patients requiring inpatient hemodialysis will be screened for participation in the study based on inclusion and exclusion criteria as noted above. Informed consent for hemodialysis and for study participation will be obtained by the attending nephrologist prior to the start of the dialysis session. Patient specific hemodialysis orders will be placed by attending nephrology physician for each patient using a standardized hemodialysis order form. Citrasate® in standard concentration, with a standard blood flow of 600 -800 ml/min will be prescribed for all study patients, calcium and potassium contents of the dialysate will be determined by the attending pediatric nephrologist.
Monitoring: All patients will have routine monitoring as indicated for clinical care during each dialysis session.
Data Collection:Each treatment will be documented on a standardized hemodialysis run sheet. Data collection will be performed by any one of the researchers using a data collection sheet to ensure uniformity of data collection methods. Data to be collected includes patient demographics, admitting diagnosis, underlying renal disease, the presence of acute kidney injury versus chronic kidney disease, contraindications to heparin use and the presence of any bleeding diathesis. Dialysis specific data to be collected will include the site and type of dialysis access, dialysis prescription parameters and treatment duration. Lab data to be collected will include pre, post and intradialytic ionized calcium values, ACT values and pH and bicarbonate values. Data on the number of saline boluses required to maintain circuit patency, percent of prescribed blood flow achieved as well as any use of heparin will be collected.
Data Analysis will include
- T-test for comparison of changes in ionized calcium values, blood pH and bicarbonate values
- Percentage of patients with inadequate coagulation on citrate (ie. patients with grade III-IV streaking or required changing to heparin based dialysate)
- Percent of patients with any adverse events not accounted for during an routine dialysis session
- Cost analysis for the difference in costs using Citrasate® compared to a standard heparin based dialysis treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Procedure: Use of citrate based dialysateSingle arm for all patient receiving inpatient HD |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Admitted pediatric patients
Key inclusion criteria (1 listed)
- All pediatric patients between the ages of 0-21 years in the inpatient setting requiring hemodialysis for renal replacement therapy. These will include both patients with chronic renal failure and acute kidney injury, or any patient requiring dialysis as determined by an attending nephrologist.
Key exclusion criteria (2 listed)
- Symptomatic hypocalcemia that is refractory to treatment 24 hours prior to the start of each dialysis session
- Known liver disorder/acute liver failure with an inability to metabolize citrate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of citrate based dialysateUse of heparin free citrate based dialysate | Procedure or surgery | Single arm |
Primary outcome
Dialyzer Clotting Rate
Time frame: Followed until HD with Citrate dialysate is discontinued, average 3 weeks
Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.
2 secondary outcomes
Saline Flush Rate
Time frame: Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks
Heparin Use Rate
Time frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21040414Hanevold C, Lu S, Yonekawa K. Utility of citrate dialysate in management of acute kidney injury in children. Hemodial Int. 2010 Oct;14 Suppl 1:S2-6. doi: 10.1111/j.1542-4758.2010.00483.x.
- Background: PubMed 19379358Davenport A. Anticoagulation options for pediatric hemodialysis. Hemodial Int. 2003 Apr 1;7(2):168-76. doi: 10.1046/j.1492-7535.2003.00022.x.
- Background: PubMed 20615906Cheng YL, Yu AW, Tsang KY, Shah DH, Kjellstrand CM, Wong SM, Lau WY, Hau LM, Ing TS. Anticoagulation during haemodialysis using a citrate-enriched dialysate: a feasibility study. Nephrol Dial Transplant. 2011 Feb;26(2):641-6. doi: 10.1093/ndt/gfq396. Epub 2010 Jul 8.
- Background: PubMed 19265544Gabutti L, Lucchini B, Marone C, Alberio L, Burnier M. Citrate- vs. acetate-based dialysate in bicarbonate haemodialysis: consequences on haemodynamics, coagulation, acid-base status, and electrolytes. BMC Nephrol. 2009 Mar 5;10:7. doi: 10.1186/1471-2369-10-7.
- Individual participant dataSharing planned: No. Mean data will be presented
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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.
Rita D Sheth, MD principal investigator
Loma Linda University
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 Complication of Dialysis, run by Loma Linda University at 1 site in United States.
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 1 inclusion and 2 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 10 Nov 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dialyzer Clotting Rate (time frame: Followed until HD with Citrate dialysate is discontinued, average 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590550, which also lists 4 linked publications.
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 10 Nov 2020.