Albumin To Enhance Recovery After Acute Kidney Injury

Официальное название

Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial

Обзор

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. An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.

Подробное описание

Background: Severe Acute Kidney Injury that necessitates renal replacement therapy (AKI-RRT) is a frequent complication of critical illness and portends severe outcomes: high morbidity, an approximately 50% risk of in-hospital death, and increased healthcare resource utilization. Although life-saving when needed, RRT itself may contribute to the poor outcomes associated with AKI-RRT. Since RRT treatments frequently cause hypotension, repeated episodes of kidney and other organ ischemia may occur during RRT. Hypotension during RRT is often triggered by fluid removal. At the same time, there is some evidence that more aggressive ultrafiltration could be beneficial in AKI-RRT.

Albumin is a protein that is the primary contributor to the colloid oncotic pressure maintaining the effective circulating volume (ECV) during RRT. Critically ill patients with AKI-RRT are nearly always hypoalbuminemic. Despite its high cost and limited evidence to support the practice, intravenous hyperoncotic albumin is commonly administered to patients with AKI-RRT in an effort to boost the colloid oncotic pressure and maintain the blood pressure while simultaneously facilitating fluid removal

Objective:

This proposed trial is intended to provide definitive evidence as to the efficacy of a frequently used and expensive intervention to promote hemodynamic stability and augment ultrafiltration during RRT in critically ill patients

Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of five Canadian tertiary care hospitals with plans to expand to include other centres across Canada and internationally.

Study Population: 856 patients admitted to the Intensive Care Unit (ICU) with AKI requiring treatment with RRT .

Intervention: Participants will be randomized 1:1 to receive either albumin (20-25%) boluses or normal saline placebo boluses at the start and halfway through RRT sessions in ICU, during their RRT treatments to a maximum of 14 days.

Вмешательства

• Биопрепарат 20-25% Albumin fluid (100 mL)
  Participants will be randomized to receive albumin (20-25%) during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours).
• Другое 0.9% Normal Saline (100 mL)
  Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (e.g. for 8 hour SLED sessions, at 0 and 4 hours; for 4 hour IHD sessions, at 0 and 2 hours; for CRRT, after starting/randomiza

Первичные конечные точки

• Organ-support-free days (OSFD) [Срок оценки: 28 days following randomization]

Вторичные конечные точки (12)

• RRT-free days through day 28 [Срок оценки: Through day 28]
• Vasoactive therapy free days [Срок оценки: Through day 28]
• Mechanical ventilation-free days [Срок оценки: Though day 28.]
• ICU free days [Срок оценки: Through 28 days]
• Number of participants with death in ICU [Срок оценки: Through 28 days]
• Number of participants with all-cause mortality at 28 days [Срок оценки: Through 28 days]
• Number of participants with all-cause mortality at 90 days [Срок оценки: Through 90 days.]
• Number of participants with death in ICU, at 28 days, and in-hospital [Срок оценки: Through 90 days]
• Number of participants with RRT dependence at 90 days among surviving patients [Срок оценки: Through 90 days.]
• Number of participants with composite of death or RRT dependence at 90 days [Срок оценки: Through 90 days.]
• eGFR will be evaluated in all patients alive at Day 90 [Срок оценки: At 90 days]
• Major adverse kidney outcomes, defined as death, RRT dependence, or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR) at 90 days. [Срок оценки: Through 90 days]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 16 центров

• The Governors of the University of Calgary — Calgary
• University of Manitoba - Health Sciences Centre — Winnipeg
• Nova Scotia Health Authority — Halifax
• Hamilton Health Sciences Corporation — Hamilton
• Kingston General Hospital — Kingston
• Sunnybrook Health Sciences Centre — North York
• The Ottawa Hospital — Ottawa
• University of Ottawa Heart Institute — Ottawa
• … и ещё 8 центров

Публикации

• Ullrich EK, Callum J, Clark EG. Use of Intravenous Albumin in Nephrology Practice Should Be Guideline-Based. J Am Soc Nephrol. 2025 Apr 30;36(7):1446-1449. doi: 10.1681/ASN.0000000750. No abstract available. PMID 40305120

Идентификаторы

NCT: NCT04705896 · CRF1819

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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