Trial document




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  DRKS00005333

Trial Description

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Title

Effects of remote ischemic preconditioning in cardiac surgery on incidence and severity of acute kidney injury

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Trial Acronym

RenalRIP

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URL of the Trial

[---]*

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Brief Summary in Lay Language


Acute kidney injury is a well-recognized complication after cardiac surgery with cardiopulmonary bypass.

Remote ischemic preconditioning will be induced by three cycles of right upper limb ischemia.

The aim of the study is to evaluate how the remote ischemic preconditioning effects the incidence of acute kidney injury in patients with cardiac surgery.

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Brief Summary in Scientific Language

Cardiopulmonary bypass is employed in most cardiac surgeries, and although the mechanisms are not fully understood, ensuing ischemic, inflammatory, and oxidative injuries to renal tubular epithelial cells have been implicated in the cause of acute kidney injury.

Despite numerous clinical trials of pharmacologic interventions, a means to prevent acute kidney injury associated with cardiac surgery has remained elusive.

Ischemic preconditioning is an innate tissue adaptation elicited by ischemia that mediates local and remote organ protection against subsequent exposure to the same or other injury.

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Organizational Data

  •   DRKS00005333
  •   2013/11/05
  •   [---]*
  •   yes
  •   Approved
  •   2013-497-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   05-AnIt-13 
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Health Condition or Problem studied

  •   N17 -  Acute renal failure
  •   OPS-2013: 5-35, 5-361 (bypass surgery, cardiac valve and septum surgery)
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Interventions/Observational Groups

  •   Ischemic preconditioning:
    Three cycles of upper limb ischemia (5-min blood-pressure cuff inflation to a pressure that is 50 mm Hg higher than the systolic arterial pressure and 5-min cuff deflation)
  •   No ischemic preconditioning:
    Three cycles of upper limb "pseudo-ischemia" (low pressure: 5-min blood-pressure cuff inflation to a pressure of 20 mmHg) without any limb ischemia
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Incidence of acute renal failure

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Secondary Outcome

- Severity of acute kidney injury (AKIN criteria)
- Duration of renal replacement therapy
- Recovery of renal function (Incidence of RRT (renal replacement therapies) on hospital discharge and 3 months after surgery)
- Length of ICU stay
- Length of hospitalization
- Laboratory parameter (creatinine on hospital discharge)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/31
  •   240
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Cardiac Surgery with the use of cardiopulmonary bypass
2. Clevelandscore of 6 or more
3. Informed consent

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Exclusion Criteria

1. pre-existing AKI
2. kidney transplantation
3. chronic kidney disease with a GFR < 30 ml/min
4. myocardial infarction within the past 7 days
5. peripheral vascular disease affecting the upper limbs
6. hepatorenal syndrome
7. pregnancy
8. drug therapy with sulfonamide and nicorandil

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Addresses

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    • Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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    • Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Mr.  Prof. Dr.  Alexander  Zarbock 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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    • Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Ms.  Dr.  Carola  Wempe 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Mr.  Prof. Dr.  Alexander  Zarbock 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/23
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Trial Publications, Results and other Documents

  •   Zarbock et al. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial.JAMA. 2015 Jun 2;313(21):2133-41.
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* This entry means the parameter is not applicable or has not been set.