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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001701-13 | EudraCT Number |
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Very low recruitment rates
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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Aalborg University Hospital | OTHER |
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The objective of this pilot trial is to assess the feasibility of forced fluid removal in patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid overload. The intervention will use furosemide infusion and/or continuous renal replacement therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention will be compared to standard of care as reflected in the kidney disease improving global outcome (KDIGO) guidelines.
Acute kidney injury (AKI) is a common and serious complication in patients admitted to ICU. A core element of critical care is resuscitation with crystalloid solutions. In many cases fluid accumulates and patients become fluid overloaded (positive fluid balance > 10% of bodyweight). This is especially true in patients with AKI, since they often have impaired ability to excrete salt and water. Most observational suggests harm with increased positive fluid balance.
Objectives: To assess feasibility of forced fluid removal with diuretics and/or CRRT in ICU patients with AKI and severe fluid overload, compared to current clinical practice.
Design: Multicentre, parallel group, randomized, assessor blinded pilot-trial with adequate generation of allocation sequence, and allocation concealment.
Trial Size: The pilot study is planned to include 50 patients. Inclusion is expected to start in August 2015.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forced Fluid Removal | Experimental | The experimental intervention is guided by a therapeutic goal of average negative fluid balance ≥ 1 ml/kg/h and safety variables indicating inadequate circulation (lactate ≥ 4, MAP < 50 or mottling beyond the edge of kneecaps). The effect of fluid removal is evaluated three times daily (06:00. 14:00 and 22:00), while the safety variables are evaluated continuously. Resuscitation is started if one or more signs of inadequate circulation is present. The first choice for fluid removal is diuretic therapy with furosemide, which is continued for a minimum of 8 hours. If the therapeutic goal (negative fluid balance ≥ 1 ml/kg/h) is not achieved and/or maintained by furosemide alone, then fluid removal with continuous renal replacement therapy (CRRT) is initiated. |
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| Usual Care | Active Comparator | Usual Care at the discretion of the treating clinicians, except for the initiation of renal replacement therapy (RRT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide (Furix) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative fluid balance | Calculated as the sum of daily intake - daily output, as registered on the daily ICU observation charts. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative fluid balance | participants will be followed for the duration of ICU stay, an expected average of 10 days | ICU stay expected average of 10 days |
| Mean daily fluid balance | participants will be followed for the duration of ICU stay, an expected average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 90 days | |
| Days alive and out of hospital | 90 days | |
| Days alive and out of mechanical ventilation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morten H Bestle, MD, Ph D | Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care. | Principal Investigator |
| Anders Perner, Md, Ph D | Rigshospitalet. ITA 4131 / Dept of Intensive Care | Study Chair |
| Jens-Ulrik Jensen, MD, Ph D | Rigshospitalet, University of Copenhagen CHIP, Department of Infectious Diseases and Rheumatology, Section 2100 | Study Chair |
| Michael Ibsen, MD, Ph D | Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care. | Study Chair |
| Rasmus E Berthelsen, MD | Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Universitetshospital, Anæstesi og intensiv afdeling | Aalborg | 9000 | Denmark | |||
| Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29664109 | Derived | Berthelsen RE, Perner A, Jensen AK, Rasmussen BS, Jensen JU, Wiis J, Behzadi MT, Bestle MH. Forced fluid removal in intensive care patients with acute kidney injury: The randomised FFAKI feasibility trial. Acta Anaesthesiol Scand. 2018 Aug;62(7):936-944. doi: 10.1111/aas.13124. Epub 2018 Apr 17. | |
| 28438182 | Derived |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D004487 | Edema |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D000079664 | Continuous Renal Replacement Therapy |
| D012151 | Resuscitation |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Continuous renal replacement therapy (CRRT) | Other |
|
|
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| Resuscitation | Other | The physiologic response to fluid removal is monitored with three variables indicating inadequate circulation. These are:
Mottling and MAP are monitored continuously and lactate is measured routinely 4-6 times each day and on clinical indication. If one or more variable is present:
|
|
| Usual Care | Other | All interventions are performed at the discretion of the treating physician apart from initiation of renal replacement therapy which is discouraged unless one or more of the following criteria are met:
|
|
| ICU stay expected average of 10 days |
| Major protocol violations | participants will be followed for the duration of ICU stay, an expected average of 10 days | ICU stay expected average of 10 days |
| Time to neutral cumulative fluid balance | No. of days until neutral cumulative fluid balance is achieved. Participants will be followed until neutral fluid balance is achieved or they reach the end of the observation period (90 days) | 90 days |
| Accumulated serious adverse reactions | Serious adverse reactions related to fluid removal(atrial fibrillation, ischemic events and organ failure), furosemide (severe electrolyte disturbance, severe thrombocytopenia, hearing loss agranulocytosis and allergic reactions) and the infusion of noradrenaline (cerebral hemorrhage, cardiac arrhythmia, psychiatric symptoms) will be examined | 90 days |
| 90 days |
| Days alive and out of renal replacement therapy | 90 days |
| Renal recovery | Defined as 5 consecutive days of:
| 90 days |
| Hillerød |
| 3400 |
| Denmark |
| Rigshospitale. ITA 4131 / Dept. of intensive care | København Ø | 2100 | Denmark |
| Berthelsen RE, Itenov T, Perner A, Jensen JU, Ibsen M, Jensen AEK, Bestle M. Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial. Trials. 2017 Apr 24;18(1):189. doi: 10.1186/s13063-017-1935-2. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D004638 | Emergency Treatment |