REVERSE-AKI Randomized Controlled Pilot Trial

Critical Illness Clinical Trial

— REVERSE-AKI  

Official title:

REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251131
• Other study ID #: HUS/1782/2017
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: December 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18-years or older and admitted to critical care with an arterial line in place

2. The patient has been in critical care for at least 12 hours but no more than 72 hours

3. The patient has AKI but is not receiving acute RRT:

For the purpose of the study AKI is defined the by the following criteria:

1. Increase in serum creatinine over 1.5-times above baseline without a decline of 27umol/l or more from the last preceding measurement (at least 12 hours apart) AND/OR

2. Overall urine output less than 0.5ml/kg/h (or 6ml/kg) for the previous 12h (with urine catheter in place for the period)

4. The patient is judged by the treating clinician not to be intravascularly hypovolemic

5. The patient is likely to remain in critical care for 48 hours after randomization

Exclusion Criteria:

1. Active bleeding necessitating transfusion

2. Maintenance fluid therapy is necessary due to diabetic ketoacidosis, non-ketotic coma, severe burns or other clinical reason determined by the medical staff

3. Need for RRT due to intoxication of a dialyzable toxin

4. Commencement of RRT is expected in the next 6 hours

5. On chronic renal replacement therapy (maintenance dialysis or renal transplant)

6. Presence or a strong clinical suspicion of parenchymal AKI (for example glomerulonephritis, vasculitis, acute interstitial nephritis), or post-renal obstruction

7. Severe hyponatremia (Na <125mmol/L) or hypernatremia (Na >155mmol/L)

8. Need for extracorporeal membrane oxygenation or molecular absorbent recirculating system (MARS-therapy)

9. Pregnant or lactating

10. Patients who are not to receive full active treatment

11. No baseline creatinine available

12. Lack of consent

13. The patient has been enrolled in another trial where co-enrollment is not feasible

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness

Intervention

Other:
• Restrictive fluid management
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.

Locations

Country	Name	City	State
Australia	Canberra Hospital	Canberra
Australia	Austin Hospital	Melbourne	Victoria
Belgium	Ghent University Hospital	Ghent
Finland	Helsinki University Hospital	Helsinki
Switzerland	Lausanne University Hospital	Lausanne
United Kingdom	Guy's and St Thomas Hospital	London
United Kingdom	Royal London Hospital, Barts Health NHS Trust	London

Sponsors (6)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Austin Hospital, Melbourne Australia, Guy's and St Thomas' NHS Foundation Trust, Lausanne University Hospital, Medical University Innsbruck, University Hospital, Ghent

Countries where clinical trial is conducted

Australia,  Belgium,  Finland,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	7 days
Other	Mechanical ventilation free days alive		14 days
Other	Vasopressor free days and alive		14 days
Other	Renal replacement therapy free days and alive		90 days
Other	Dialysis dependence		90 days
Other	All-cause mortality		90 days
Primary	Cumulative fluid balance		72 hours
Secondary	Duration of acute kidney injury	Defined according to Kidney Disease: Improving Global Outcomes criteria	ICU discharge/14 days
Secondary	Number of patients requiring renal replacement therapy		14 days
Secondary	Cumulative fluid balance		24 hours
Secondary	Cumulative fluid balance		ICU discharge/ 7 days
Secondary	Cumulative dose of diuretics		ICU discharge/ 7 days