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Impact of Amount of Fluid for Circulatory Resuscitation on Renal Function in Patients in Shock (VoluKid)

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ClinicalTrials.gov Identifier: NCT02666404
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Volume resuscitation is the mainstay of treatment in most types of shock, especially in hemorrhagic and septic shock. Septic shock is a main cause of morbidity and mortality worldwide. Although there has been a lot of research to evaluate optimal amount and composition of fluids for volume resuscitation (e.g. colloids, crystalloids, red blood cell transfusion, albumin, fresh frozen plasma) particularly in the past decade, results remain inconclusive and to some extent contradictive. The investigators would like to contribute to the establishment of new endpoints for the guidance of shock therapy focusing on the first 24 and 48 hours, amending the currently used parameters (i.e. cardiac output, heart rate, blood pressure, central venous pressure) with new measurements (see study specific measurements). The goal is to decrease the need for renal replacement therapy, thereby eventually reducing patient morbidity and mortality.

Condition or disease Intervention/treatment Phase
Shock Other: Measurement Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Amount of Fluid for Circulatory Resuscitation on Renal Function in Patients in Shock: Evaluating the Combination of Intraabdominal Pressure and Renal Resistive Index With Hemodynamic Parameters for Guidance of Shock Therapy - A Multicenter International Clinical Trial
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests Shock

Arm Intervention/treatment
Experimental: Volume Resuscitation
We would like to establish new endpoints for guidance of volume resuscitation by implementing new measurements (body impedance, renal resistive index).
Other: Measurement
We will perform those new measurements and assessments for guidance of fluid resuscitation at 0, 6, 24, 48, and 72 hours after shock diagnosis and concomitant fulfillment of eligibility requirements
Other Names:
  • Body Impedance Measurement
  • Renal Resistive Index
  • Intra-abdominal Pressure




Primary Outcome Measures :
  1. Acute kidney injury (KDIGO staging for severity of acute kidney injury ). [ Time Frame: Assessment at 0, 6, 24, 48, and 72 hours after shock diagnosis ]
    Change in renal function from baseline according to KDIGO staging


Secondary Outcome Measures :
  1. Difference in lactate values (µmol/l) [ Time Frame: Between 6 and 24 hours after admittance to the ICU and baseline (t1/t2 - t0) ]
  2. Need for renal replacement therapy (KDIGO staging for severity of acute kidney injury) [ Time Frame: Assessment at 0, 6, 24, 48, and 72 hours after shock diagnosis ]
  3. Length of ICU stay [ Time Frame: 1 month ]
    If Patient stay exceeds one month, we will assess the data at intervals of one month

  4. Length of hospital stay [ Time Frame: 1 month ]
    If Patient stay exceeds one month, we will assess the data at intervals of one month

  5. Need for mechanical ventilation [ Time Frame: During 27 hours ]
  6. In-hospital, 30-, and 90-day mortality [ Time Frame: 0-90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • State of shock (any type) upon admittance to the ICU.

Exclusion Criteria:

  • Age below 18 years
  • Non-shock state
  • Terminal state
  • Pregnancy
  • Jehovah's Witnesses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666404


Contacts
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Contact: Alexa Hollinger, MD 0041 61 328 65 08 alexa.hollinger@usb.ch
Contact: Martin Siegemund, MD 0041 61 328 64 14 martin.siegemund@usb.ch

Locations
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Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Alexa Hollinger, MD    0613286508    alexa.hollinger@usb.ch   
Contact: Martin Siegemund, MD    0613286414    martin.siegemund@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Martin Siegemund, MD Deputy Chief Physician, Surgical Intensive Care Unit

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02666404     History of Changes
Other Study ID Numbers: EKNZ 2015-401
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Average Acute Physiology And Chronic Health Evaluation (APACH) II score/SAPS II score/SOFA score/KDIGO criteria

Keywords provided by University Hospital, Basel, Switzerland:
Volume Resuscitation
Shock
Body Impedance Measurement
Renal Resistive Index
Acute Kidney Injury
Renal Replacement Therapy

Additional relevant MeSH terms:
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Shock
Pathologic Processes