BridgeMD
New treatment option for Acute Kidney Injury
Official title Albumin To Enhance Recovery After Acute Kidney Injury
ClinicalTrials.gov ID: NCT04705896
What this study is testing
What is 20-25% Albumin fluid (100 mL)?
20-25% Albumin fluid (100 mL) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study objectives: To determine whether, in critically ill patients with Acute Kidney Injury requiring renal replacement therapy (AKI-RRT), randomization to receive intravenous hyperoncotic albumin 20-25% (100 mL X two doses) compared to control/placebo normal saline boluses (100 mL X two doses) given during RRT sessions, leads to: 1. An increase in organ support-free days (primary outcome) at 28 days following randomization; and 2.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old;
- Admission to a critical care unit/intensive care unit (ICU) for \> 24 hours;
- Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (including non-invasive mechanical ventilation (NIMV));
- Immediate initiation of RRT for management of AKI is planned OR additional RRT sessions are imminently planned for patients who already received RRT...
You likely can't join if
- Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;
- Known pre-hospitalization end-stage kidney disease;
- Kidney transplant within the past 365 days;
- Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute...
- Advanced cirrhosis (Child Pugh class C [score 10-15]), spontaneous bacterial peritonitis or hepatorenal syndrome;
- Acute peritoneal dialysis used as the initial RRT modality;
See the full eligibility criteria
- Age ≥18 years old;
- Admission to a critical care unit/intensive care unit (ICU) for \> 24 hours;
- Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (including non-invasive mechanical ventilation (NIMV));
- Immediate initiation of RRT for management of AKI is planned OR additional RRT sessions are imminently planned for patients who already received RRT during their ICU admission;
- Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;
- Known pre-hospitalization end-stage kidney disease;
- Kidney transplant within the past 365 days;
- Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis;
- Advanced cirrhosis (Child Pugh class C [score 10-15]), spontaneous bacterial peritonitis or hepatorenal syndrome;
- Acute peritoneal dialysis used as the initial RRT modality;
- Contraindications to albumin:
- Admitted with traumatic brain injury
- Increased intra-cranial pressure in those with intra-cranial pressure monitoring
- Prior history of anaphylaxis to intravenous albumin
- Contraindication or known objection to albumin/blood product transfusions
- Already received 2 or more RRT sessions during ICU admission.
- Limitations of medical therapy precluding RRT/mechanical ventilation/vasoactive medications or plan to transition to palliation
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Winnipeg, Manitoba, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- North York, Ontario, Canada
- Ottawa, Ontario, Canada
- Scarborough Village, Ontario, Canada
- St. Catharines, Ontario, Canada
- Toronto, Ontario, Canada
- Whitby, Ontario, Canada
- Laval, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; North York, Ontario, Canada and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.