Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adherence to suggested guidance
研究概览
简要总结
The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin?
Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.
详细描述
This randomized, open-label, pilot feasibility trial will assess a volume assessment guidance algorithm (VAGA) in patients with AKI and cirrhosis. Eligible patients must have AKI and decompensated cirrhosis. In addition to assessing the adherence to the suggested guidance, this study will measure the effect of the study intervention on grams of albumin given, clinical efficacy outcomes (AKI response rates, survival, RRT status, transplant status), and safety.
Patients who meet eligibility criteria will be randomized 1:1 where the treating clinicians will receive a one-time recommendation for volume resuscitation using the VAGA or standard of care IV albumin repletion (1 g/kg/day for two days). Both groups will be followed with assessments at 48 hours after randomization, hospital discharge, and 90-days after randomization.
The primary efficacy outcome, grams of albumin, will be measured at 48 hours after randomization. Primary secondary efficacy outcomes (grams of albumin, AKI response) will be assessed at time of hospital discharge. If a patient undergoes liver transplantation or initiation of RRT during the admission, this will serve as a censoring date for these outcomes, and relevant data will be collected at the time of the first of these events.
The primary feasibility outcome is adherence to the suggested guidance, assessed at 48 hours after randomization. The VAGA group will receive one of three potential clinical recommendations: (a) no further volume resuscitation, (b) resuscitation with crystalloid, or (c) resuscitation with colloid.
This study will prospectively enroll approximately 50 adult patients at a single center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age 18 years or greater
- •Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally authorized representatives prior to initiation of any study procedures.
- •Admitted to the hospital
- •Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).
- •Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg/dL within 48 hours or ≥50% increase from baseline which is known or presumed to have occurred within the prior 7 days.
排除标准
- •Requiring >2 liters (L) supplemental oxygen at the time of screening.
- •In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).
- •Allergy or other contraindication to IV albumin administration.
- •Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.
- •Patient and/or legally authorized representative unable to provide informed consent.
- •Hepatic encephalopathy grade 3 or 4 at the time of screening.
- •Already received >200 g albumin during admission at the time of screening.
- •Severe, active bleeding requiring 3 or more units of red blood cell transfusion in the 48 hours prior to screening.
- •Admission to the intensive care unit at the time of screening.
- •Mechanical ventilation at the time of screening.
- •Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.
- •History of prior liver or kidney transplant.
- •Pregnant or nursing status
- •Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.
研究组 & 干预措施
VAGA Group
This group will receive an algorithm-based recommendation based on the 2024 Acute Disease Quality Initiative (ADQI)/International Club of Ascites (ICA) joint consensus meeting on AKI in cirrhosis, which recommends a personalized approach to AKI in cirrhosis in order to avoid volume overload. This includes balanced crystalloids as first-line resuscitative fluids unless there is a patient-specific indication for an alternative colloid (e.g. blood for gastrointestinal bleeding, IV albumin for spontaneous bacterial peritonitis or suspicion of hepatorenal syndrome), or no further resuscitation.
干预措施: Recommendation: No Further Resuscitation (Other)
VAGA Group
This group will receive an algorithm-based recommendation based on the 2024 Acute Disease Quality Initiative (ADQI)/International Club of Ascites (ICA) joint consensus meeting on AKI in cirrhosis, which recommends a personalized approach to AKI in cirrhosis in order to avoid volume overload. This includes balanced crystalloids as first-line resuscitative fluids unless there is a patient-specific indication for an alternative colloid (e.g. blood for gastrointestinal bleeding, IV albumin for spontaneous bacterial peritonitis or suspicion of hepatorenal syndrome), or no further resuscitation.
干预措施: Recommendation: Resuscitation with Crystalloid (Other)
VAGA Group
This group will receive an algorithm-based recommendation based on the 2024 Acute Disease Quality Initiative (ADQI)/International Club of Ascites (ICA) joint consensus meeting on AKI in cirrhosis, which recommends a personalized approach to AKI in cirrhosis in order to avoid volume overload. This includes balanced crystalloids as first-line resuscitative fluids unless there is a patient-specific indication for an alternative colloid (e.g. blood for gastrointestinal bleeding, IV albumin for spontaneous bacterial peritonitis or suspicion of hepatorenal syndrome), or no further resuscitation.
干预措施: Recommendation: Resuscitation with Colloid (Other)
Standard of Care
This group will receive a recommendation based on the 2021 American Association for the Study of Liver Diseases (AASLD) and 2018 European Association for the Study of the Liver (EASL) clinical practice guidelines, which recommends a 1 g/kg/d IV albumin (maximum 100 g/day) IV albumin over 2 days as an initial resuscitation approach for patients with AKI and cirrhosis.
干预措施: Recommendation: Standard of Care IV Albumin (Other)
结局指标
主要结局
Adherence to suggested guidance
时间窗: From date of randomization up to 48 hours
For the VAGA group, adherence is defined as: No further resuscitation (\<500 mL total volume of IV fluid given), Resuscitation with crystalloid (\>500 mL total IV fluid given, with \<50 g IV albumin and ≤2 units blood), Resuscitation with colloid (≥50 g IV albumin or ≥2 units blood given). For the Standard of Care group, adherence is defined as receiving within 20% of the suggested IV albumin dose in grams.
Incidence of treatment-emergent adverse events and serious adverse events
时间窗: From date of randomization up to hospital discharge, assessed up to 90 days
IV albumin received (grams)
时间窗: From date of randomization up to 48 hours
次要结局
- AKI Response(From date of randomization up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.)
- Renal Replacement Therapy Initiation(From date of randomization up to 90 days)
- Liver transplant(From date of randomization up to 90 days)
- IV albumin received (grams)(From date of hospital admission up to hospital discharge, or the date of time of initiation of renal replacement therapy or liver transplant, whichever came first, assessed up to 90 days.)
- Vital Status(From date of randomization up to 90 days)
研究者
Andrew S. Allegretti, MD, MSC
Director of Critical Care Nephrology
Massachusetts General Hospital