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| Name | Class |
|---|---|
| Université de Montréal | OTHER |
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The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy.
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, often leading to fluid overload. Congestion resulting from fluid accumulation is believed to contribute to organ failure. Removal of excess fluid is a central component of dialysis treatment, also known as kidney replacement therapy (KRT). However, there remain important knowledge gaps in our ability to remove excess fluid effectively and safely. If fluid is removed too slowly, fluid overload and its complications persist for longer. If fluid is removed too fast during KRT, patient's blood pressure may drop (ie hemodynamic instability may occur) which may precipitate complications.
The optimal fluid management strategy is currently unknown.
The PROBE Fluid UK study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with AKI receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.
The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later. Secondary outcomes will include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protocol-based fluid removal | Experimental | The intervention will consist of 3 components: The first component of this prescription will be to define the 24h-fluid balance target. The second component is to specify a prescription for fluid removal. The third component is to prompt a daily re-evaluation of fluid intake and fluid balance by the attending care team. |
|
| Usual care | No Intervention | Fluid removal during KRT will be determined by the attending clinical team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid removal | Procedure | Fluid removal during kidney replacement therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| fluid balance | cumulative fluid balance | day 5 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| enrolment | Proportion of eligible patients who were enrol in the trial | 20 months |
| mortality | all-cause mortality | 90 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlies Ostermann (work), PhD | Contact | 02071887188 | 83036 | marlies.ostermann@gstt.nhs.uk |
| Gillian Radcliffe | Contact | 02071887188 | 83036 | Gillian.Radcliffe@gstt.nhs.uk |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ICU stay | Number of ICU free days | 90 days after randomization |
| vasoactive therapy | Number of vasoactive therapy-free days | 28 days after randomization |
| mechanical ventilation | Number of mechanical ventilation-free days | 28 days after randomization |
| KRT duration | hours of KRT support | 5 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |