How well do the kidneys work in critically ill patients in intensive care
| ISRCTN | ISRCTN49147498 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49147498 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 59.14.0000.138.001.16.0002.24.72 |
| Sponsor | National Institute of Traumatology & Orthopaedic Rehabilitation |
| Funder | Directorate General of Medical Education (DGME) |
- Submission date
- 25/10/2025
- Registration date
- 15/11/2025
- Last edited
- 11/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims:
The kidneys filter waste products and excess fluids from the body. In certain critically ill patients in the intensive care unit (ICU), the kidneys may function faster than usual - this is known as Augmented Renal Clearance (ARC). As a result, essential medications can be eliminated from the body too quickly, reducing their effectiveness. This study seeks to determine how frequently ARC occurs in ICU patients and to identify related factors, enabling doctors to adjust medication dosages more precisely.
Who can participate?
Adults (aged 18 years or older) admitted to the ICU who are clinically stable and do not have severe kidney disease will be invited to take part in the study.
What does the study involve?
Participants will undergo 24-hour urine collection to assess kidney function. Blood samples will also be taken to measure creatinine levels, which help estimate kidney performance. Additional clinical data, such as age, illness severity, fluid balance, and medications, will be recorded. Taking part will not influence the patient’s treatment or care.
What are the possible benefits and risks of participating?
There are no direct benefits for participants, but the results may help improve future medication prescribing for critically ill patients. Risks are minimal and limited to routine sample collection procedures.
Where is the study run from?
The study is being carried out at the National Institute of Traumatology and Orthopaedic Rehabilitation (NITOR) in Dhaka, Bangladesh.
When is the study starting and how long is it expected to run for?
The study is scheduled to begin in December 2025 and will run for about 12 months.
Who is funding the study?
The Directorate General Medical Education (DGME) is funding this study through the 2025–26 Research Grant Program.
Who is the main contact?
Dr Syed Tariq Reza, drtariq@nitor.gov.bd
Contact information
Public, Scientific, Principal investigator
Intensive care Unit (ICU), National Institute of Trauma & Orthopaedic Rehabilitation (NITOR)
Sher E Bangla Nagar
Dhaka
1207
Bangladesh
| Phone | +880 (0)1712679616 |
|---|---|
| drtariq@nitor.gov.bd |
Public, Scientific
Department of Community Medicine
Shaheed Suhrawardy medical College
Sher E Bangla Nagar Dhaka
Dhaka
1207
Bangladesh
| Phone | +880 (0)1716491494 |
|---|---|
| syedanusrat18@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Augmented renal clearance in patients admitted to the intensive care unit: a prospective observational study |
| Study acronym | ARC-ICU |
| Study objectives | This prospective observational study investigates the prevalence of augmented renal clearance (ARC) in adult patients admitted to the intensive care unit (ICU) for more than 24 hours. ARC is defined as a 24-hour measured creatinine clearance (CrCl) ≥120 mL/min/1.73 m². The study also aims to identify demographic, physiological, and clinical risk factors associated with ARC, compare measured and estimated CrCl values, and evaluate the impact of ARC on clinical outcomes, including ICU length of stay, mortality, and treatment response. |
| Ethics approval(s) |
Approved 16/10/2024, Institutional Ethical Review Board (IERB) (Shaheed Suhrawardy Medical College, Sher E Bangla Nagar, Dhaka, 1207, Bangladesh; +880 (0)29130295; principal_shsmc@yahoo.com), ref: 59.14.0000.138.001.16.0002.24.72 |
| Health condition(s) or problem(s) studied | Augmented renal clearance (ARC) in critically ill patients |
| Intervention | Eligible adult ICU patients (≥18 years) will undergo serial 24-hour urine collections on days 1, 3, 5, and 7 of ICU admission. In non-catheterized patients: Urine collection begins after the bladder is emptied, followed by a complete 24-hour collection in a refrigerated or ice-cooled container. In catheterized patients: The urine bag is emptied at the start of collection and every 2 hours thereafter into a refrigerated or ice-cooled container. Urinary creatinine concentrations will be measured enzymatically. Serum creatinine will be measured 12 hours after the start of urine collection. CrCl24h will be calculated and normalized to a body surface area (BSA) of 1.73 m². Demographic and clinical data (age, sex, BSA, admission diagnosis, vital signs, APACHE II, SOFA scores, fluid balance, vasopressor and antibiotic use, comorbidities) and laboratory results (serum creatinine, urine creatinine, measured and estimated CrCl) will be recorded. ARC is defined as CrCl >130 mL/min/1.73 m². Patients will be followed for 28 days or until discharge/death for outcome analysis (ICU length of stay, mortality, treatment response). |
| Intervention type | Other |
| Primary outcome measure(s) |
Prevalence of ARC (≥120 mL/min/1.73 m²) as measured by 24-hour urinary creatinine clearance within first 7 days of ICU admission |
| Key secondary outcome measure(s) |
1. Risk factors associated with ARC (demographic, physiological, and clinical parameters) within the first 7 days of ICU admission |
| Completion date | 15/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Adults aged ≥18 years 2. ICU stay ≥24 hours 3. Informed consent obtained from patient or legal representative |
| Key exclusion criteria | 1. Chronic kidney disease (CKD stage ≥3 or baseline eGFR <60 mL/min) 2. Receiving renal replacement therapy 3. Kidney transplant recipients 4. Pregnant or lactating women 5. Incomplete urine collection or missing laboratory data 6. Hemodynamic instability precluding safe sampling |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Bangladesh
Study participating centres
Sher E Bangla Nagar
Dhaka
1207
Bangladesh
Shaheed Suhrawardy Medical College
Sher e Bangla Nagar
Dhaka
1207
Bangladesh
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request to the principal investigator Dr Syed Tariq Reza (rezatariq7@gmail.com) Type of data shared: De-identified clinical and laboratory data concerning renal clearance measurements and patient characteristics. Dates of availability: The data will be accessible upon reasonable request following publication of the main findings (anticipated in 2027). Consent for data sharing: Consent for anonymized data use will be obtained from each participant or their legal guardian. Data anonymization: All personal identifiers will be removed before data sharing. Ethical/legal restrictions: Data sharing will adhere to institutional ethics approvals and national data protection regulations. Additional comments: The study team will review data requests and approve them based on research relevance and ethical compliance. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/10/2025: Study's existence confirmed by the Institutional Ethical Review Board (IERB).
