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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Remote ischemic preconditioning (RIPC) Three Cycles of 5-min upper limb ischemia. If there is no response this will be followed by 2 cycles of 10-min upper-limb ischemia. |
|
| Control Group | Sham Comparator | Three cycles of 5- min upper limb sham ischemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning (RIPC) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 24h after randomization and [TIMP-2]*[IGFBP7] levels at randomization | from randomization to 24 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria | 72 hours after the onset of sepsis | |
| Severity of AKI | The severity for AKI is classified according to the KDIGO criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Add-on Study (Analysis of further proteins) | from randomization until 24 hours after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie Meersch-Dini, MD | Contact | +49-251-8347255 | meersch@uni-muenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Melanie Meersch-Dini, MD | University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine | Recruiting | Münster | 48149 | Germany |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D058186 | Acute Kidney Injury |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
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|
| Sham RIPC | Procedure | 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 |
|
| 72 hours after the onset of sepsis |
| Need for renal replacement therapy | Number of patients with renal replacement therapy | 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 | day 90 after the onset of sepsis |
| Mortality | 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 | day 90 after the onset of sepsis |
| Length of Intensive Care Unit (ICU) stay | up to 90 days after onset of sepsis |
| Length of hospital stay | up to 90 days after onset of sepsis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |