Long Term Renal Function After CRRT in the Paediatric Intensive Care Unit, a Follow-up Study.

NCT05629273 | Completed

• 1 other identifier: 2022-01669-02
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will evaluate the long-term renal function in children treated with continuous renal replacement therapy (CRRT) due to acute kidney injury (AKI) and multiple organ failure (MOF) in the pediatric intensive care unit (PICU). These children are not always referred for nephrology follow up after their ICU stay and it is unclear to what extent the patients suffer from chronic renal disease. The primary aim is to establish the frequency of chronic kidney disease (CKD) in children treated with CRRT due to AKI. Secondary outcomes will include mortality, frequency of end stage-renal disease (ESRD) and need for hemodialysis and/or renal transplantation.

Conditions

Acute Kidney Injury; Multi Organ Failure; Children, Only

Keywords

Acute kidney injury; Multi organ failure; Children; Long term complications; Chronic renal damage

Outcome Measures

Primary Outcomes (2)

• Chronic renal disease (CKD)

  Frequency of chronic renal disease (CKD) according to KDIGO definitions at nephrology follow-up.

  Up to12 years.

• Chronic renal disease (CKD)

  Frequency of chronic renal disease according to ICD diagnosis in Swedish National Patient Register.

  Up to 12 years

Secondary Outcomes (7)

• Hypertension

  Up to 12 years

• End-stage renal disease

  Up to 12 years

• Hypertension

  Up to 12 years

• Dialysis Therapy.

  Up to 12 years

• Renal transplantation

  Up to 12 years

Study Arms (1)

Children treated with continuous renal replacement therapy in the intensive care unit.

Children treated with CRRT in the ICU due to AKI stage ≥1 (according to KDIGO) and/or ≥2 organ failures. The aim is to evaluate their long term renal function and establish the frequency of chronic kidney disease. Nephrology follow up will be done by a pediatric nephrologist for children living in the Stockholm area or have ongoing care at Karolinska University Hospital. Due to high mortality in this group of patients and the fact that many patients are referred to Karolinska University Hospital from other regions in Sweden, a substantial number of patients will be lost to follow-up. The investigators will therefore conduct a register-based study of all children who received CRRT due to AKI and/or MOF at Karolinska University Hospital from 2008-2021. Data regarding mortality, cause of death and diagnosis of chronic renal disease will be collected from the Swedish National Patient Register and National Cause of Death Register.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children treated with CRRT in the intensive care unit.

You may qualify if:

• \- Age newborn to 18 when admitted to ICU. CRRT treatment 2008-2021 due to AKI stage ≥ stage 1 (according to KDIGO) and/or ≥ 2 organ failures

You may not qualify if:

• CRRT due to metabolic and/or endocrinologic comorbidity.
• Chronic renal failure before CRRT.
• Previous renal transplantation.
• Prospective part:
• \- Not a resident of Stockholm County and no planned follow up at Karolinska University Hospital.
• Retrospective part:
• \- Patient referred to Karolinska University Hospital from a hospital outside Sweden.

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Pediatric Perioperative Medicine and Intensive Care

Stockholm, Sweden, 171 76, Sweden

Location

Related Publications (10)

• Almarza S, Bialobrzeska K, Casellas MM, Santiago MJ, Lopez-Herce J, Toledo B, Carrillo A. [Long-term outcomes of children treated with continuous renal replacement therapy]. An Pediatr (Barc). 2015 Dec;83(6):404-9. doi: 10.1016/j.anpedi.2014.12.018. Epub 2015 Feb 13. Spanish.

  PMID: 25683273 BACKGROUND

• Andersson A, Norberg A, Broman LM, Martensson J, Flaring U. Fluid balance after continuous renal replacement therapy initiation and outcome in paediatric multiple organ failure. Acta Anaesthesiol Scand. 2019 Sep;63(8):1028-1036. doi: 10.1111/aas.13389. Epub 2019 Jun 3.

  PMID: 31157412 BACKGROUND

• Sutherland SM, Zappitelli M, Alexander SR, Chua AN, Brophy PD, Bunchman TE, Hackbarth R, Somers MJ, Baum M, Symons JM, Flores FX, Benfield M, Askenazi D, Chand D, Fortenberry JD, Mahan JD, McBryde K, Blowey D, Goldstein SL. Fluid overload and mortality in children receiving continuous renal replacement therapy: the prospective pediatric continuous renal replacement therapy registry. Am J Kidney Dis. 2010 Feb;55(2):316-25. doi: 10.1053/j.ajkd.2009.10.048. Epub 2009 Dec 30.

  PMID: 20042260 BACKGROUND

• Wu L, Zhang P, Yang Y, Jiang H, He Y, Xu C, Yan H, Guo Q, Luo Q, Chen J. Long-term renal and overall survival of critically ill patients with acute renal injury who received continuous renal replacement therapy. Ren Fail. 2017 Nov;39(1):736-744. doi: 10.1080/0886022X.2017.1398667.

  PMID: 29199512 BACKGROUND

• Askenazi DJ, Feig DI, Graham NM, Hui-Stickle S, Goldstein SL. 3-5 year longitudinal follow-up of pediatric patients after acute renal failure. Kidney Int. 2006 Jan;69(1):184-9. doi: 10.1038/sj.ki.5000032.

  PMID: 16374442 BACKGROUND

• Hayes LW, Oster RA, Tofil NM, Tolwani AJ. Outcomes of critically ill children requiring continuous renal replacement therapy. J Crit Care. 2009 Sep;24(3):394-400. doi: 10.1016/j.jcrc.2008.12.017. Epub 2009 Mar 27.

  PMID: 19327959 BACKGROUND

• Diane Mok TY, Tseng MH, Chiang MC, Lin JL, Chu SM, Hsu JF, Lien R. Renal replacement therapy in the neonatal intensive care unit. Pediatr Neonatol. 2018 Oct;59(5):474-480. doi: 10.1016/j.pedneo.2017.11.015. Epub 2017 Dec 21.

  PMID: 29396136 BACKGROUND

• Morelli S, Ricci Z, Di Chiara L, Stazi GV, Polito A, Vitale V, Giorni C, Iacoella C, Picardo S. Renal replacement therapy in neonates with congenital heart disease. Contrib Nephrol. 2007;156:428-33. doi: 10.1159/000102134.

  PMID: 17464154 BACKGROUND

• Calderon-Margalit R, Golan E, Twig G, Leiba A, Tzur D, Afek A, Skorecki K, Vivante A. History of Childhood Kidney Disease and Risk of Adult End-Stage Renal Disease. N Engl J Med. 2018 Feb 1;378(5):428-438. doi: 10.1056/NEJMoa1700993.

  PMID: 29385364 BACKGROUND

• Mammen C, Al Abbas A, Skippen P, Nadel H, Levine D, Collet JP, Matsell DG. Long-term risk of CKD in children surviving episodes of acute kidney injury in the intensive care unit: a prospective cohort study. Am J Kidney Dis. 2012 Apr;59(4):523-30. doi: 10.1053/j.ajkd.2011.10.048. Epub 2011 Dec 28.

  PMID: 22206744 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Urban Fläring

  Children Perioperative Medicine & Intensive Care, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 29, 2022
• Study Start: January 20, 2022
• Primary Completion: October 12, 2024
• Study Completion: October 12, 2024
• Last Updated: July 31, 2025

Record last verified: 2024-04

Locations

SE (1)