Acute Kidney Injury Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Regional Anticoagulation With Citrate in Extended Hemodialysis in Patients With Acute Renal Injury Admitted to an Intensive Care Unit
Verified date | September 2021 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Data on regional citrate anticoagulation in patients with acute kidney injury (AKI) treated by hybrid or extended dialysis are scarce and heterogeneous. The path batch system (Genius®) or the proportion hemodialysis machines are well suited equipments to perform extended dialysis. However, clotting of the system might occur with relatively high frequency, especially in critically ill patients with high risk of clotting or in those with contraindication to the use of heparin. The aims of this study are: 1) to test and to validate a new protocol using citrate to perform regional anticoagulation in AKI patients admitted to the intensive care unit (ICU) and treated by extended dialysis, using a control group (use of heparin or intermittent saline flush) as comparison in the Heart Institute of the university medical complex "Clinics Hospital Medical School at São Paulo" (Hospital das Clínicas da Faculdade de Medicina do Estado de São Paulo) and at the Cancer Institute of the São Paulo State; 2) to evaluate the anticoagulation in these procedures with citrate and compare with the control group using heparin or saline flush, so the primary end point would be the rates of system clotting; 3) to study the calcium mass transfer in these procedures and its impact on bone metabolism in these patients. The inclusion criteria are all AKI patients admitted in these places and candidates to renal replacement therapy using the extended dialysis, age above 18 years. The exclusion criteria are acute liver failure, hemorrhagic stroke, platelets level below 20,000/mm3, and active bleeding needing transfusional support (two or more red cell packs in 24 hours).
Status | Suspended |
Enrollment | 200 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients with acute kidney injury admitted to the intensive care unit and candidates for extended dialysis (renal replacement therapy) - Age over 18 years. Exclusion Criteria: - Acute liver failure - Hemorrhagic stroke in the last 30 days - Patients with platelet levels below 20,000/mm3 - Active bleeding requiring transfusion (two or more red blood cell packs within 24 hours) |
Country | Name | City | State |
---|---|---|---|
Brazil | University of São Paulo Medical School | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Hospital do Cancer, Sao Paulo, InCor Heart Institute |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clotting rate | Clotting of the dialysis system with complete impossibility to continue the therapy | through all dialysis session, an average of 8 hours | |
Secondary | Parathyroid hormone (PTH), Fibroblast growth factor-23 (FGF-23), Procollagen type 1 N-terminal propeptide (P1NP), Esclerostin and Telopeptide carboxiterminal of type I collagen (cTX) | Serum hormone levels will be evaluated before the dialysis session | through all dialysis session, an average of 8 hours | |
Secondary | Dialysate calcium | Dialysate calcium will be evaluated to address the calcium balance | through all dialysis session, an average of 8 hours | |
Secondary | Serum ionized and total calcium levels | Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours. | through all dialysis session, an average of 8 hours | |
Secondary | Serum sodium concentration | Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours. | through all dialysis session, an average of 8 hours | |
Secondary | Serum potassium concentration | Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours. | through all dialysis session, an average of 8 hours | |
Secondary | Serum bicarbonate | Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours. | through all dialysis session, an average of 8 hours | |
Secondary | Serum phosphorus | Measurement before and after the dialysis session. | through all dialysis session, an average of 8 hours | |
Secondary | Serum magnesium | Measurement before and after the dialysis session. | through all dialysis session, an average of 8 hours | |
Secondary | Serum creatinine concentration | Measurement before and after the dialysis session. | through all dialysis session, an average of 8 hours | |
Secondary | Serum urea concentration | Measurement before and after the dialysis session. | through all dialysis session, an average of 8 hours | |
Secondary | Parathyroid hormone (PTH) concentration | Serum hormone levels will be evaluated before the dialysis session | two measurements per patient (before the dialysis initiation and at the end, after an average of 8 hours) | |
Secondary | Fibroblast growth factor-23 (FGF-23) concentration | Serum hormone levels will be evaluated before the dialysis session | baseline, before the dialysis initiation | |
Secondary | Procollagen type 1 N-terminal propeptide (P1NP) concentration | Serum hormone levels will be evaluated before the dialysis session | baseline, before the dialysis initiation | |
Secondary | Sclerostin concentration | Serum hormone levels will be evaluated before the dialysis session | baseline, before the dialysis initiation | |
Secondary | Telopeptide carboxyterminal of type I collagen (cTX) concentration | Serum hormone levels will be evaluated before the dialysis session | baseline, before the dialysis initiation | |
Secondary | Mean arterial pressure | Patients in dialysis will have their blood pressure recorded every hour | every hour in the dialysis session (an average of 8 hours) | |
Secondary | Heart rate | Patients in dialysis will have their heart rate recorded every hour | every hour in the dialysis session (an average of 8 hours) | |
Secondary | Respiratory rate | Patients in dialysis will have their respiratory rate recorded every hour | every hour in the dialysis session (an average of 8 hours) | |
Secondary | Temperature | Patients in dialysis will have their temperature rate recorded every hour | every hour in the dialysis session (an average of 8 hours) |
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