A Phase 2 interventional study of Restrictive fluid management in Acute Kidney Injury and Critical Illness, sponsored by Helsinki University Central Hospital. Completed at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-14.
Sponsored by Helsinki University Central Hospital · Phase 2, Interventional, and Treatment
Among 23 studies in Acute Kidney Injury with a site in Australia — 3 open to participants now, 4 under way, none of them phase 3. Acute Kidney Injury · Australia.
Among the 23 studies in Acute Kidney Injury with a site in Australia, this one is the 10th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2017, is one of 6 in phase 2, and was the 13th registered.
1,691 studies on the registry are indexed under Acute Kidney Injury; 394 are open to participants now.
Browse Acute Kidney Injury studies →3 of the 23 studies in Acute Kidney Injury with a site in Australia are open now. Recruiting first, the newest first:
Uppsala University · Sites in Australia, Brazil, Canada and 7 more countries
Ages 0–16
Indiana University · Sites in Australia, United States, Argentina and 30 more countries
Ages 0 min–2 wk
Australian and New Zealand Intensive Care Research Centre · Sites in Australia
Ages 18–65
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 230 Acute Kidney Injury studies recruiting now, 161 (70%) set no upper age limit and 36 (16%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 4 · Phase 4 2
First in 2005; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is close to the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Median enrollment 208 across the 18 interventional studies, 2,000 across the 5 observational. Of the 18 that completed or were terminated, 4 (22%) have results posted.
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5 of 23 have an industry lead sponsor. The 10 most frequent:
Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Helsinki University Central Hospital has 4 studies filed under Acute Kidney Injury — fewer than ten, so there is no comparison to draw.
3 of the studies in Acute Kidney Injury with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07579390Helsinki University Central HospitalEffects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) | 2026-12 |
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT07438262Australian and New Zealand Intensive Care Research CentreThe AminoECMO Pilot Trial | 2027-08-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 23 studies in Acute Kidney Injury with a site in Australia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The patient has AKI but is not receiving acute RRT:
For the purpose of the study AKI is defined the by the following criteria:
Exclusion Criteria:
Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.
Other: Restrictive fluid management
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.
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.
Cumulative fluid balance
Time frame: 72 hours
Duration of acute kidney injury
Defined according to Kidney Disease: Improving Global Outcomes criteria
Time frame: ICU discharge/14 days
Number of patients requiring renal replacement therapy
Time frame: 14 days
Cumulative fluid balance
Time frame: 24 hours
Cumulative fluid balance
Time frame: ICU discharge/ 7 days
Cumulative dose of diuretics
Time frame: ICU discharge/ 7 days
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
Time frame: 7 days
Mechanical ventilation free days alive
Time frame: 14 days
Vasopressor free days and alive
Time frame: 14 days
Renal replacement therapy free days and alive
Time frame: 90 days
Dialysis dependence
Time frame: 90 days
All-cause mortality
Time frame: 90 days
Ran from Nov 2017 to primary completion in Jan 2020, 26 months.
Of 39 non-industry phase 2 interventional studies under Acute Kidney Injury, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's 26 months is below that.
Counting every sponsor, half of 57 studies reached it within 29 months; a quarter within 16 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital →