Acute Kidney InjuryHEFCAANCT03836742
HEmoFiltration With Citric Acid Anticoagulation
An observational study of Acute Kidney Injury and Acute Kidney Failure, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Prospective observational study of all consecutive cardio-vascular surgical patients treated with post-dilution hemofiltration with regional citrate anticoagulation as first-choice anticoagulation method. The filter life-span was assessed in the context of postoperative cardiac surgical antithrombotic prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Failure, Renal Replacement Therapy
- What is being tested?
- Hemofiltration with regional citrate anticoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 sitePoland
- Study dates
- 11 Aug 2015to 31 Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive cardio-vascular surgery patients treated with post-dilution hemofiltration with regional citrate anticoagulation from August 2015 through November 2017
Who may be able to join
- cardiac and vascular surgery patients treated with continuous hemofiltration with regional citrate anticoagulation
Who cannot join
- severe chronic liver disease, acute liver injury with INR > 2, and refractory shock with lactate increasing above 8 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of a Regional Anticoagulation Protocol for Continuous Renal Replacement Therapies.
Prospective observational study of all consecutive cardio-vascular surgical patients treated with post-dilution hemofiltration with regional citrate anticoagulation as first-choice anticoagulation method. The filter life-span was assessed in the context of postoperative cardiac surgical antithrombotic prophylaxis. Reasons for termination of hemofiltration sessions were assessed. The second aim of this study was to assess the influence ACD-A based anticoagulation protocol on acid-base and ion homeostasis in cardiac surgical patients with acute renal failure.
Read the detailed description
All consecutive cardio-vascular surgery patients treated with post-dilution hemofiltration with regional citrate anticoagulation (HF RCA) from August 2015 through November 2017 were included to prospective audit. Indication to hemofiltration treatment was based on clinical assessment of patients renal function and clinical status by attending physician and conformed conventional indications to renal replacement therapy (RRT) in intensive care unit (ICU). Severe chronic liver disease or acute liver injury with INR > 2 and refractory shock with lactate increasing above 8 mmol/L were considered as contraindication to RCA.
Initially set blood flow was 5 times higher than filtrate flow, which makes filtration fraction of 20%. To reduce the risk of metabolic alkalosis, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution, and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which should reduce bicarbonate synthesis by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor.
In order to avoid hypomagnesemia resulting from magnesium binding to citrate, and its removal with ultrafiltrate not balanced with magnesium content in replacement fluid, the original protocol was modified by connecting magnesium sulfate solution 2g/50 ml 0.9% NaCl at the flow 1 mL/hour.
All sessions stopped due to patients death before 48 hours of HF treatment were excluded from the analysis. Similarly, all cases where hemofiltration session was stopped before 48 hours of treatment due to organizational reasons, recovery of renal function, change of therapy, and when patients were treated with heparin infusion due to surgical indications were excluded from further circuit survival analysis.
Blood gas parameters together with pH, bicarbonate concentration, Na, Cl, K, Ca, hemoglobin concentration, hematocrit, lactate, and anion gap were analyzed every 6 hours. Post filter ionized calcium concentration was not assessed. Serum phosphate, magnesium and total calcium was assessed every 24 hours during hemofiltration treatment with RCA.
- Being tested
- Hemofiltration with regional citrate anticoagulation
- 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.
Hemofiltration with regional citrate anticoagulationProcedure or surgery
To reduce risk of metabolic alkalosis during hemofiltration treatment, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which reduced bicarbonate delivery by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor.
| Study group | Role | What they receive |
|---|---|---|
| HF RCA | Cardiovascular surgery patients treated with hemofiltration with regional citrate anticoagulation Receives: Procedure: Hemofiltration with regional citrate anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemofiltration circuit survival time
in hours
Measured: up to 120 hours from the beginning of hemofiltration session
Incidence of metabolic alkalosis
Arterial blood pH>7.5 or BE > 40 mmol/L
Measured: From the beginning of hemofiltration session until 6 hours after its end
Incidence of hypernatremia and hyponatremia
Incidence of hypernatremia> 150 mmol/L and hyponatremia < 130 mmol/L in arterial blood sample
Measured: From the beginning of hemofiltration session until 6 hours after its end
Secondary outcomes (1)
Incidence of citrate accumulation
Incidence of total to ionized calcium ratio > 2,5 in arterial blood sample
Measured: From the beginning of hemofiltration session until 24 hours after its end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start11 Aug 2015
- Primary completion10 Nov 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romuald Lango, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836742
- Sponsor's protocol ID
- NKBBN/539/2016-17
- Acronym
- HEFCAA
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD are to be shared with other researcher
Publications
Kirwan CJ, Hutchison R, Ghabina S, Schwarze S, Beane A, Ramsay S, Thompson E, Prowle JR. Implementation of a Simplified Regional Citrate Anticoagulation Protocol for Post-Dilution Continuous Hemofiltration Using a Bicarbonate Buffered, Calcium Containing Replacement Solution. Blood Purif. 2016;42(4):349-355. doi: 10.1159/000452755. Epub 2016 Nov 19.
PubMed 27866200
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of a Regional Anticoagulation Protocol for Continuous Renal Replacement Therapies.
- ClinicalTrials.gov ID
- NCT03836742
- Acronym / sponsor ID
- HEFCAA / NKBBN/539/2016-17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 11 Aug 2015 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Feb 2019 (actual)
- 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.
Prospective observational study of all consecutive cardio-vascular surgical patients treated with post-dilution hemofiltration with regional citrate anticoagulation as first-choice anticoagulation method. The filter life-span was assessed in the context of postoperative cardiac surgical antithrombotic prophylaxis. Reasons for termination of hemofiltration sessions were assessed. The second aim of this study was to assess the influence ACD-A based anticoagulation protocol on acid-base and ion homeostasis in cardiac surgical patients with acute renal failure.
Detailed description
All consecutive cardio-vascular surgery patients treated with post-dilution hemofiltration with regional citrate anticoagulation (HF RCA) from August 2015 through November 2017 were included to prospective audit. Indication to hemofiltration treatment was based on clinical assessment of patients renal function and clinical status by attending physician and conformed conventional indications to renal replacement therapy (RRT) in intensive care unit (ICU). Severe chronic liver disease or acute liver injury with INR > 2 and refractory shock with lactate increasing above 8 mmol/L were considered as contraindication to RCA.
Initially set blood flow was 5 times higher than filtrate flow, which makes filtration fraction of 20%. To reduce the risk of metabolic alkalosis, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution, and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which should reduce bicarbonate synthesis by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor.
In order to avoid hypomagnesemia resulting from magnesium binding to citrate, and its removal with ultrafiltrate not balanced with magnesium content in replacement fluid, the original protocol was modified by connecting magnesium sulfate solution 2g/50 ml 0.9% NaCl at the flow 1 mL/hour.
All sessions stopped due to patients death before 48 hours of HF treatment were excluded from the analysis. Similarly, all cases where hemofiltration session was stopped before 48 hours of treatment due to organizational reasons, recovery of renal function, change of therapy, and when patients were treated with heparin infusion due to surgical indications were excluded from further circuit survival analysis.
Blood gas parameters together with pH, bicarbonate concentration, Na, Cl, K, Ca, hemoglobin concentration, hematocrit, lactate, and anion gap were analyzed every 6 hours. Post filter ionized calcium concentration was not assessed. Serum phosphate, magnesium and total calcium was assessed every 24 hours during hemofiltration treatment with RCA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF RCA | – | Procedure: Hemofiltration with regional citrate anticoagulationCardiovascular surgery patients treated with hemofiltration with regional citrate anticoagulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive cardio-vascular surgery patients treated with post-dilution hemofiltration with regional citrate anticoagulation from August 2015 through November 2017
Key inclusion criteria (1 listed)
- cardiac and vascular surgery patients treated with continuous hemofiltration with regional citrate anticoagulation
Key exclusion criteria (1 listed)
- severe chronic liver disease, acute liver injury with INR > 2, and refractory shock with lactate increasing above 8 mmol/L
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 |
|---|---|---|
| Hemofiltration with regional citrate anticoagulationTo reduce risk of metabolic alkalosis during hemofiltration treatment, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which reduced bicarbonate delivery by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor. | Procedure or surgery | HF RCA |
Primary outcome
Hemofiltration circuit survival time
Time frame: up to 120 hours from the beginning of hemofiltration session
in hours
Incidence of metabolic alkalosis
Time frame: From the beginning of hemofiltration session until 6 hours after its end
Arterial blood pH>7.5 or BE > 40 mmol/L
Incidence of hypernatremia and hyponatremia
Time frame: From the beginning of hemofiltration session until 6 hours after its end
Incidence of hypernatremia> 150 mmol/L and hyponatremia < 130 mmol/L in arterial blood sample
1 secondary outcome
Incidence of citrate accumulation
Time frame: From the beginning of hemofiltration session until 24 hours after its end
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 15 Feb 2019.
- Background: PubMed 27866200Kirwan CJ, Hutchison R, Ghabina S, Schwarze S, Beane A, Ramsay S, Thompson E, Prowle JR. Implementation of a Simplified Regional Citrate Anticoagulation Protocol for Post-Dilution Continuous Hemofiltration Using a Bicarbonate Buffered, Calcium Containing Replacement Solution. Blood Purif. 2016;42(4):349-355. doi: 10.1159/000452755. Epub 2016 Nov 19.
- Individual participant dataSharing planned: No. No IPD are to be shared with other researcher
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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.
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 Kidney Injury and Acute Kidney Failure, run by Medical University of Gdansk at 1 site in Poland.
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 1 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 15 Feb 2019. 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 Poland. 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?
Hemofiltration circuit survival time (time frame: up to 120 hours from the beginning of hemofiltration session). The study lists 3 primary outcomes in all. 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 NCT03836742, which also lists 1 linked publication.
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 15 Feb 2019.