NCT03736005

Brief Summary

This study aims to determine changes in kidney function during and after critical illness, comparing conventional creatinine based methods with the gold standard to accurately establish the presence of new or worsened chronic kidney disease. In addition, investigators will assess the confounding effect of muscle wasting on the conventional assessment of kidney function and investigate the information that measures of kidney function may contribute to the assessment of musculoskeletal health after critical illness.

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 Dec 2018

Typical duration 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

First Submitted

Initial submission to the registry

August 28, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 19, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

August 28, 2018

Last Update Submit

September 13, 2022

Conditions

Critical IllnessAcute Kidney InjuryMuscle LossMajor TraumaQuality of LifeChronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in estimated Glomerular Filtration Rate (eGFR) between creatinine- and cystatin C-based estimates.

    At 7 days after ICU discharge.

Secondary Outcomes (13)

  • Rectus Femoris muscle wasting

    From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge. Time period up to and including 18 months from recruitment.

  • Diagnosis of a negative Nitrogen Balance

    From ICU admission (day 1 to 10) and 7 days after ICU discharge.

  • Respiratory muscle wasting

    From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.

  • Loss of muscle quality

    From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.

  • Loss of functional capacity

    7 days and 6 months after ICU discharge.

  • +8 more secondary outcomes

Study Arms (2)

General ICU admissions

Non- major trauma ICU admission Exposure to significant period of critical illness

Other: Exposure of significant critical illness

Major Trauma admissions

Exposure to Major Trauma Exposure to significant period of critical illness

Other: Exposure of significant critical illness

Interventions

Exposure of significant critical illnessOTHER

Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.

General ICU admissionsMajor Trauma admissions

Eligibility Criteria

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

Adult patients admitted to critical care.

You may qualify if:

  • Major trauma cohort: Patients ≥18y admitted to ICU and anticipated to be mechanically ventilated for ≥48 hours with a primary admission diagnosis of major trauma.
  • Non-trauma cohort: Patients ≥18y admitted to ICU and anticipated to be mechanically ventilated for ≥48 hours without a primary admission diagnosis of major trauma.

You may not qualify if:

  • Death or discharge from hospital considered highly likely by treating physician within 7 days of ICU admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal London Hospital

London, E11BB, United Kingdom

Location

Related Publications (2)

  • Ravn B, Prowle JR, Martensson J, Martling CR, Bell M. Superiority of Serum Cystatin C Over Creatinine in Prediction of Long-Term Prognosis at Discharge From ICU. Crit Care Med. 2017 Sep;45(9):e932-e940. doi: 10.1097/CCM.0000000000002537.

    PMID: 28614196BACKGROUND

  • Haines RW, Fowler AJ, Liang K, Pearse RM, Larsson AO, Puthucheary Z, Prowle JR. Comparison of Cystatin C and Creatinine in the Assessment of Measured Kidney Function during Critical Illness. Clin J Am Soc Nephrol. 2023 Aug 1;18(8):997-1005. doi: 10.2215/CJN.0000000000000203. Epub 2023 May 31.

    PMID: 37256861DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Quadriceps muscle tissue, blood and urine

MeSH Terms

Conditions

Critical IllnessAcute Kidney InjuryMuscular AtrophyRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsChronic Disease

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

November 8, 2018

Study Start

December 19, 2018

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)