EUCTR2015-001701-13-DK
Active, not recruiting
Phase 1
Forced fluid removal vs. usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI) – A randomized clinical trial - FFAKI-trial
ordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.0 sitesJuly 1, 2015
ConditionsFluid overload associated with acute kidney injury in patients admitted to the intensive care unitMedDRA version: 18.0Level: PTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 18.0Level: PTClassification code 10016803Term: Fluid overloadSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 18.0Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsFurix
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Fluid overload associated with acute kidney injury in patients admitted to the intensive care unit
- Sponsor
- ordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 years of age
- •Acute Kidney Injury defined according to the KDIGO criteria
- •Renal Recovery Score \= 50%. (Calculated using www.renal\-recovery\-score.com)
- •Fluid overload defined as a positive fluid balance \= 10% of admission body weight.
- •Able to undergo randomization within 12 hours of fulfilling other inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 20
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Known allergy to furosemide or sulphonamides
- •Known pre\-hospitalization advanced chronic kidney disease (GFR \< 30 mL/minute/1\.73 m2 or chronic RRT).
- •Severe hypoxic respiratory failure (use of invasive ventilation and FiO2 \> 80% and PEEP \> 10 cm H2O)
- •Severe burn injury (\= 10% TBSA)
- •Severe dysnatremia (\< 120 or \> 155 mmol/l)
- •Hepatic coma
- •Mentally disabled undergoing forced treatment
- •Pregnancy/breast feeding
- •Lack of commitment for on\-going life support including RRT
- •Lack of informed consent
Outcomes
Primary Outcomes
Not specified
Similar Trials
Terminated
Phase 4
Forced Fluid Removal in High Risk Acute Kidney InjuryAcute Kidney InjuryFluid OverloadCritical IllnessNCT02458157Nordsjaellands Hospital21
Not yet recruiting
Not Applicable
A study to evaluate the practice of Fluid Therapy in very sick patients on mechanical ventilatorCTRI/2024/06/068806Amsterdam University Medical Centers, location ‘AMC’
Completed
Not Applicable
Compare adequate intraoperative fluid therapy with Ondansetron on the incidence and severity of nausea and vomiting after general surgeryAnesthesia.Symptoms and signs involving the digestive system and abdomenR10-119IRCT2016080219359N6Vice Chancellor for Research, North Khorasan University of Medical Sciences120
Completed
Not Applicable
Compare adequate intraoperative fluid therapy with dexamethasone on the incidence and severity of nausea and vomiting after generalAnesthesia.Symptoms and signs involving the digestive system and abdomenR10-119IRCT2016122019359N8Vice Chancellor for Research, North Khorasan University of Medical Sciences120
Not yet recruiting
Not Applicable
Resuscitation strategy in obstetric hemorrhage.Post partum hemorrhage, restritive fluid resuscitation, coagulopathyNL-OMON22968Maastricht Universitair Medisch Centrum250