NCT02560402

Brief Summary

Aim of the present study is to determine whether

  1. 1.RRI can predict glomerular hyperfiltration;
  2. 2.glomerular hyperfiltration is associated with low renal resistive index;
  3. 3.glomerular hyperfiltration/low RRI are associated with accelerated flow in the sublingual microcirculation;
  4. 4.glomerular hyperfiltration/low RRI are related to fluid status as quantified with bioimpedance analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

September 22, 2015

Last Update Submit

May 9, 2016

Conditions

TraumaSepsis

Keywords

Glomerular hyperfiltrationRenal Resistive Index (RRI)

Outcome Measures

Primary Outcomes (1)

  • Renal Resistive Index (RRI)

    1 week

Secondary Outcomes (3)

  • 4-h Creatinine clearance

    1 week

  • Microvascular flow index of the sublingual microcirculation

    1 week

  • Resistance, as measured with bioimpedance as a marker of fluid status.

    1 week

Study Arms (1)

Patients with sepsis or trauma

Adult patients, admitted to the intensive or medium care unit with sepsis or trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients, admitted to the intensive or medium care unit with sepsis or trauma

You may qualify if:

  • Admission to the intensive or medium care unit
  • Sepsis or trauma
  • Age \> 18 years

You may not qualify if:

  • Patients
  • with chronic renal insufficiency (eGFR \< 30 ml)
  • with renal transplant kidney
  • on chronic dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (9)

  • Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21.

    PMID: 22617274BACKGROUND

  • Udy A, Boots R, Senthuran S, Stuart J, Deans R, Lassig-Smith M, Lipman J. Augmented creatinine clearance in traumatic brain injury. Anesth Analg. 2010 Dec;111(6):1505-10. doi: 10.1213/ANE.0b013e3181f7107d. Epub 2010 Nov 3.

    PMID: 21048095BACKGROUND

  • Udy AA, Roberts JA, Shorr AF, Boots RJ, Lipman J. Augmented renal clearance in septic and traumatized patients with normal plasma creatinine concentrations: identifying at-risk patients. Crit Care. 2013 Feb 28;17(1):R35. doi: 10.1186/cc12544.

    PMID: 23448570BACKGROUND

  • Fuster-Lluch O, Geronimo-Pardo M, Peyro-Garcia R, Lizan-Garcia M. Glomerular hyperfiltration and albuminuria in critically ill patients. Anaesth Intensive Care. 2008 Sep;36(5):674-80. doi: 10.1177/0310057X0803600507.

    PMID: 18853585BACKGROUND

  • Udy AA, Roberts JA, Boots RJ, Paterson DL, Lipman J. Augmented renal clearance: implications for antibacterial dosing in the critically ill. Clin Pharmacokinet. 2010;49(1):1-16. doi: 10.2165/11318140-000000000-00000.

    PMID: 20000886BACKGROUND

  • Claus BO, Hoste EA, Colpaert K, Robays H, Decruyenaere J, De Waele JJ. Augmented renal clearance is a common finding with worse clinical outcome in critically ill patients receiving antimicrobial therapy. J Crit Care. 2013 Oct;28(5):695-700. doi: 10.1016/j.jcrc.2013.03.003. Epub 2013 May 14.

    PMID: 23683557BACKGROUND

  • Minkute R, Briedis V, Steponaviciute R, Vitkauskiene A, Maciulaitis R. Augmented renal clearance--an evolving risk factor to consider during the treatment with vancomycin. J Clin Pharm Ther. 2013 Dec;38(6):462-7. doi: 10.1111/jcpt.12088. Epub 2013 Aug 8.

    PMID: 23924288BACKGROUND

  • Cook AM, Arora S, Davis J, Pittman T. Augmented renal clearance of vancomycin and levetiracetam in a traumatic brain injury patient. Neurocrit Care. 2013 Oct;19(2):210-4. doi: 10.1007/s12028-013-9837-y.

    PMID: 23907742BACKGROUND

  • Udy AA, Varghese JM, Altukroni M, Briscoe S, McWhinney BC, Ungerer JP, Lipman J, Roberts JA. Subtherapeutic initial beta-lactam concentrations in select critically ill patients: association between augmented renal clearance and low trough drug concentrations. Chest. 2012 Jul;142(1):30-39. doi: 10.1378/chest.11-1671.

    PMID: 22194591BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Heleen M. Oudemans, Prof. Dr.

    Amsterdam UMC, location VUmc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 25, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)