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Timing of Renal Replacement Therapy in the Critically Ill Patients (TORRT)

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ClinicalTrials.gov Identifier: NCT03629977
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Max Bell, Karolinska University Hospital

Brief Summary:

Background: Severe acute kidney injury (AKI) among critically ill patients is sometimes treated with renal replacement therapy (RRT), and in Sweden continuous RRT (CRRT) is the dominant modality used in this population.

  • The optimal timing of renal replacement therapy (RRT) initiation in critically ill patients with acute kidney injury (AKI) is unknown
  • No consensus to guide clinical practice on this issue
  • Lack of consistency regarding outcome measurements; should we look at morbidity or mortality?
  • Wide variability in the timing of RRT initiation in the intensive care unit (ICU) population

Hypothesis: This is an important knowledge gap in the support of critically ill patients with AKI and we hypothesize that early initiation of RRT is beneficial.

Methods: The present study aims to test this hypothesis by using a large scale high resolution intensive care database, the Clinisoft repository. In this database, we have information on >60 000 patients from three different hospitals and five ICUs, during the years 2005 up until today. The repository will be crossmatched, using the unique Swedish national ID number, with hospital records; to gather information on preexisting illnesses, chronic medication and post-ICU outcomes. It is likely that over 5%, more than 3000 patients, have been treated with RRT. We will categorize these patients into "early" and "late" groups using both biomarker data and clinical data. Importantly, early and late RRT can be categorized using biomarkers, like urea and creatinine; using degree of fluid accumulation, by level of pH in blood and just by using hours-days after ICU admission. All possible definitions of early/late RRT initiation can be tested in this study.

Outcomes: Our primary outcome is 90 day mortality. Secondary outcomes include: mortality at 30, 60, 180 and 365 days. Two- and three year mortality.

Morbidity, measured as end-stage renal disease (ESRD) for 90-day survivors. ICU length of stay, hospital length of stay.


Condition or disease Intervention/treatment
Acute Kidney Injury Uremia Fluid Overload Dialysis; Complications Critical Illness Device: CRRT

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Early vs Late CRRT, a Propensity Matched Multicenter Cohort Study
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
early RRT
A patient where initiation of RRT is started without the absolute indications
Device: CRRT
Continuous Renal Replacement Therapy

late RRT

CRRT based on absolute indications.

Absolute indications:

  1. hyperkalemia (serum potassium≥6 mEq/L),
  2. severe acidosis (pH≤7.15),
  3. plasma urea>36 mmol/L (equals BUN=100.8 mg/dl),
  4. oliguria or anuria (urine output<0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours), and
  5. fluid overload with pulmonary edema as defined by the presence of all the following factors: (a) >10% fluid accumulation (cumulative fluid balance/baseline weight>10%), (b) oliguria (urine output<0.5 ml/kg per hour for ≥12 hours), and (c) severely impaired oxygenation (PaO2/FiO2<200 indicated by respiratory Sequential Organ Failure Assessment [SOFA] score≥3)
Device: CRRT
Continuous Renal Replacement Therapy

never RRT
RRT is never started, matched against early RRT group.
Device: CRRT
Continuous Renal Replacement Therapy




Primary Outcome Measures :
  1. Mortality [ Time Frame: 90-day mortality (mortality within 90 days of intensive care unit admission) ]
    Date of death


Secondary Outcome Measures :
  1. ICU Length of Stay (LOS) [ Time Frame: We will measure ICU LOS from ICU admission to ICU discharge, within 30 days of admission ]
    Number of days in ICU

  2. Hospital LOS [ Time Frame: We will measure Hospital LOS from ICU admission to hospital discharge, within 60 days of admission ]
    Number of days in hospital

  3. End Stage Renal Disease [ Time Frame: ESRD from 90 days after ICU discharge up to a maximum of 10 years ]
    Date of ESRD, from the Swedish Renal Register

  4. Mortality at other specified time-points [ Time Frame: 30-, 60-, 180-, 1-year, 2-year and 3-year mortality (mortality within those time points of intensive care unit admission) ]
    Date of death


Other Outcome Measures:
  1. Days on ventilator [ Time Frame: 90-day-follow-up; counting the days within the ICU stay on invasive ventilation ]
    Number of days on invasive ventilation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients treated in Stockholm between 2007 and 2017 in the following five ICUs from three hospitals: Karolinska University Hospital in Solna - central medico-surgical ICU; Karolinska University Hospital in Solna - cardiothoracic ICU; Karolinska University Hospital Huddinge - medico-surgical ICU; Södersjukhuset Hospital - medical ICU; Södersjukhuset Hospital - surgical ICU.
Criteria

Inclusion Criteria:

*Critically ill patients admitted to intensive care units in Stockholm at: Karolinska University Hospital (Solna and Huddinge) and at Södersjukhuset.

*Patients over 18 years of age

Exclusion Criteria:

  • Patients <18 years
  • Patients with DNAR (do not attempt resuscitation)-orders
  • Patients dying within 12 hours of commencing renal replacement therapy.

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): NCT03629977


Contacts
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Contact: Max Bell, MD, PhD +46708278533 max.bell@sll.se
Contact: Claire Rimes-Stigare, MD, PhD +46733911087 claire.rimes-stigare@sll.se

Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Max Bell, MD, PhD Karolinska Institutet
Additional Information:

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Responsible Party: Max Bell, MD, PhD, Associate Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03629977    
Other Study ID Numbers: KarolinskaUH_KING
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to share the database, once anonymized, with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes