Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03251131
Other study ID # HUS/1782/2017
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness