Acute kidney injury is a well-recognized complication in critically ill patients. Up to date there is no clinically established method to reduce the incidence or the severity of acute kidney injury. Remote ischemic preconditioning (RIPC) will be induced by three cycles of upper limb ischemia. The aim of the study is to reduce the incidence of AKI by implementing remote ischemic preconditioning (identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor-binding protein 7(IGFBP7)
Acute kidney injury (AKI) is a common complication in critically ill patients with sepsis. To date, there is no pharmacological option to treat or prevent AKI. Ischemic conditioning is an innate tissue adaptation elicited by ischemia that mediates local and remote organ protection against subsequent exposure to the same or other injury. The aim of this trial is to evaluate the effects of remote ischemic conditioning in critically ill patients on acute kidney injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
64
3 cycles of 5 min inflation of a blood-pressure cuff to 200 millimetres of mercury (mmHG) (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed.
3 cycles of 5 min inflation of a blood-pressure cuff to 20 mmHG to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed
University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster, Germany
RECRUITING1. kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 24h after randomization and [TIMP-2]*[IGFBP7] levels at randomization
Time frame: from randomization to 24 hours after randomization
Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame: 72 hours after the onset of sepsis
Severity of AKI
The severity for AKI is classified according to the KDIGO criteria
Time frame: 72 hours after the onset of sepsis
Need for renal replacement therapy
Number of patients with renal replacement therapy
Time frame: 72 hours after the onset of sepsis
Recovery of kidney function
defined as complete recovery: serum-creatinine ≤0.5 mg/dl higher than baseline; partial recovery: serum creatinine \>0.5 mg/dl higher than baseline but no dialysis-dependence; non-recovery: patients who remained dialysis-dependent
Time frame: day 90 after the onset of sepsis
Mortality
Time frame: day 90 after the onset of sepsis
Major adverse kidney events (MAKE) Composite endpoint consisting of death, renal replacement therapy, and persistent severe AKI lasting for 72 hours or more
Time frame: day 90 after the onset of sepsis
Length of Intensive Care Unit (ICU) stay
Time frame: up to 90 days after onset of sepsis
Length of hospital stay
Time frame: up to 90 days after onset of sepsis
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