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| Name | Class |
|---|---|
| Austin Hospital, Melbourne Australia | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| University Hospital, Ghent | OTHER |
| Medical University Innsbruck |
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Observational studies among patients with acute kidney injury (AKI) have shown an association with fluid accumulation and increased mortality. Trials among other subgroups of critically ill patients have demonstrated that restricting fluid input after the initial resuscitation appears safe.
The objective if this study is to determine whether a fluid restrictive treatment regimen will lead to a lower cumulative fluid balance at 72 hours from randomization in critically ill patients with AKI and whether this approach is safe and feasible.
Acute kidney injury (AKI) is common in the critically ill and associates with adverse outcomes. Patients with AKI are frequently have low urine output and are at high risk of developing fluid overload. Fluid overload has been associated with an increased risk for mortality in such patients. Previous trials in critically ill patients found that a 'restrictive fluid therapy' after resuscitation was safe. Implementing a restrictive fluid therapy approach in patients with AKI may also be of benefit. To date, however, no randomized trial has been performed to evaluate the safety and feasibility of implementing a 'restrictive fluid therapy' approach compared to standard fluid therapy in patients with AKI.
In this pilot randomized controlled trial we will evaluate the implementation of a fluid restrictive approach, compared to standard therapy, in adult critically ill patients with acute kidney injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrictive fluid management | Experimental | Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance. |
|
| Standard therapy | No Intervention | Randomized allocation of standard care at the clinician's discretion in accordance with current best practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restrictive fluid management | Other | Daily fluid input is restricted to drugs and nutrition. Fluid boluses and blood products can be given if clinically indicated. Matching fluid output to fluid input whenever possible using diuretics if needed, and additionally, if clinically necessary and plausible, commencing renal replacement therapy. If renal replacement therapy is not deemed clinically desirable, acceptance of a less than targeted fluid balance. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative fluid balance | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of acute kidney injury | Defined according to Kidney Disease: Improving Global Outcomes criteria | ICU discharge/14 days |
| Number of patients requiring renal replacement therapy | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with serious adverse events and reactions | a Ventricular tachycardia/fibrillation b. New onset of atrial fibrillation requiring medication/defibrillation c. Ischemic events i. Acute myocardial infarction ii. Cerebral ischemia verified by CT or MRI scan. iii. Intestinal ischemia verified by endoscopy or open surgery. iv. Acute peripheral limb ischemia d. Radiologically diagnosed pulmonary edema e. Adverse events related to renal replacement therapy and diuretics use f. Frequency of hypokalaemia (serum K <3.5mmol/L) g. Frequency of hypomagnesaemia (serum Mg <0.8mmol/L) h. frequency of serum pH >7.5 i. other |
Inclusion Criteria:
18-years or older and admitted to critical care with an arterial line in place
The patient has been in critical care for at least 12 hours but no more than 72 hours
The patient has AKI but is not receiving acute RRT:
For the purpose of the study AKI is defined the by the following criteria:
The patient is judged by the treating clinician not to be intravascularly hypovolemic
The patient is likely to remain in critical care for 48 hours after randomization
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suvi Vaara, MD, PhD | Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland | Principal Investigator |
| Marlies Ostermann, MD, PhD | Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Hospital | Melbourne | Victoria | 3048 | Australia | ||
| Canberra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32022904 | Derived | Vaara ST, Ostermann M, Selander T, Bitker L, Schneider A, Poli E, Hoste E, Joannidis M, Zarbock A, van Haren F, Prowle J, Pettila V, Bellomo R. Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial. Acta Anaesthesiol Scand. 2020 Jul;64(6):831-838. doi: 10.1111/aas.13557. Epub 2020 Feb 26. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| OTHER |
| University of Lausanne Hospitals | OTHER |
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|
| Cumulative fluid balance | 24 hours |
| Cumulative fluid balance | ICU discharge/ 7 days |
| Cumulative dose of diuretics | ICU discharge/ 7 days |
| 7 days |
| Mechanical ventilation free days alive | 14 days |
| Vasopressor free days and alive | 14 days |
| Renal replacement therapy free days and alive | 90 days |
| Dialysis dependence | 90 days |
| All-cause mortality | 90 days |
| Canberra |
| Australia |
| Ghent University Hospital | Ghent | Belgium |
| Helsinki University Hospital | Helsinki | Finland |
| Lausanne University Hospital | Lausanne | Switzerland |
| Guy's and St Thomas Hospital | London | United Kingdom |
| Royal London Hospital, Barts Health NHS Trust | London | United Kingdom |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |