Remote Ischemic Preconditioning in Septic Patients

ConditionsCritically Ill Acute Kidney Injury Sepsis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversität Münster

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (age ≥18 years)

Critically ill patients with sepsis < 12 hours

Invasive ventilation for at least 24 hours (propofol-free-sedation) and/or vasopressor therapy

Unrestricted intensive care for at least 72 hours

Disqualifiers

Pre-existing AKI

(Glomerulo-)nephritis, interstitial nephritis, vasculitis

Chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m²

Chronic dialysis dependency

Trial design

Design model

Parallel

Treatments tested in this trial

Remote ischemic preconditioning (RIPC)
Procedure/Surgery
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.
Sham RIPC
Procedure/Surgery
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

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: Intervention GroupExperimental treatment 1 intervention

Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

from randomization to 24 hours after randomization

Secondary outcomes

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

Other outcomes

Add-on Study (Analysis of further proteins)

Time frame

from randomization until 24 hours after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universität Münster

Lead sponsor

Source ClinicalTrials.gov

Apply now