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NCT Number: NCT02500394

Biomarker Guided Intervention for Prevention of Acute Kidney Injury

This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Center Regensburg

Regensburg, 93042, Germany

About this study

This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis). If used biomarkers are above a predefined cutoff within < 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines. In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). Degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (CVP).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

"Inclusion Criteria":

  • major surgery with a duration > 4 hours plus one of the following criteria:
  • age > 75 years, or
  • sepsis, or
  • shock, or
  • polytrauma, or
  • need for invasive ventilation or catecholamines, or
  • intra-operative application of contrast-medium, or
  • preexisting chronic kidney disease (CKD1-4),
  • informed consent

Exclusion criteria

  • age < 18 years,
  • end stage renal disease (ESRD),
  • preexisting dialysis,
  • withdrawal of consent,
  • pregnancy,
  • breastfeeding

Treatment and study plan

Ionosteril

Procedure

biomarker guided volume substitution with Ionosteril

Primary outcomes

  1. Incidence and severity of AKI in both group

    Time frame: 90 days

    incidence and severity of AKI according to AKI network definition within 90 days will be monitored

Secondary outcomes

  1. need for renal replacement therapy,

    Time frame: 90 days

    Number of participants with a need for renal replacement therapy (defined as dialysis within 90 days)

  2. length of ICU stay

    Time frame: 90 days

    overall length of ICU stay

  3. length of hospital stay

    Time frame: 90 days

    overall length of ICU stay

  4. ICU and hospital costs

    Time frame: 90 days

    to account for resulting costs, ICU and hospital cost of the standard care and the interventional patient population are monitored

  5. incidence of chronic kidney disease (CKD)

    Time frame: 90 days

    Investigators want to see if there are any differences on resulting renal function - different stages of chronic kidney disease (CKD I-V) as a consequence of the performed therapy: standard care accoring to KDIGO guidelines versus interventional care

  6. death

    Time frame: 90 days

    overall mortality

Sponsors and collaborators

Lead sponsor

University Hospital Regensburg

Other

Registry information

Official study title

Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients

Acronym: BigpAK

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 16, 2015
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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