Fluid BalanceNCT07338734
Fluid Balance in Acute Kidney Injury in Critically Ill Patients
An observational study of Fluid Balance and Acute Kidney Injury, run by Assiut University.
Trial summary
This prospective observational cohort study evaluates if fluid balance in the first 48 hours of ICU admission is linked to acute kidney injury (AKI) in critically ill adults. Patients without AKI at entry will have fluids tracked hourly via charts, weights, and labs to assess AKI risk by KDIGO criteria within 7 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Balance, Acute Kidney Injury, Critically Ill Acute Kidney Injury
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients aged 18 years or older admitted to the intensive care unit (ICU) at Assiut University Hospital without acute kidney injury (AKI) at admission. Eligible cases include prerenal, renal, postrenal AKI with hypovolemia; postoperative; CKD up to stage IIIb; compensated heart failure needing fluids.
Who may be able to join
- Adults aged 18 years or older admitted to the ICU.
- Patients with no AKI at ICU admission.
- AKI secondary to (prerenal cause-renal and post renal with manifestation of hypovolemia)-postoperative settings-On top of CKD up to Stage 111b-Compansated heart failure with indication of fluid therapy
Who cannot join
- Patients with pre-existing end-stage renal disease requiring dialysis.
- Patients with known chronic kidney disease stage 4 or higher.
- ICU readmissions during the same hospitalization.
- Patients who received renal replacement therapy before ICU admission
- Patients with AKI with manifestation of over load as pulmonary edema- pulmonary embolism-Acute decompensated heart failure
About this study
Official title: Fluid Balance During Early Hours of Acute Kidney Injury in Critically Ill Patients
This prospective observational cohort study evaluates if fluid balance in the first 48 hours of ICU admission is linked to acute kidney injury (AKI) in critically ill adults. Patients without AKI at entry will have fluids tracked hourly via charts, weights, and labs to assess AKI risk by KDIGO criteria within 7 days. Findings may guide better fluid management to lower AKI rates.
Read the detailed description
This prospective observational cohort study at Assiut University Hospital ICU investigates the association between fluid balance in the first 48 hours of admission and acute kidney injury (AKI) development. Critically ill adults (≥18 years) without AKI at baseline will undergo routine monitoring: hourly fluid intake/output (IV fluids, blood products, urine, drains, insensible losses), daily weights, serial labs (SCr, BUN, electrolytes, albumin, CRP), and clinical/hemodynamic assessments. AKI is defined/staged by KDIGO criteria within 7 days. Sample size is 120 (Epi-Info calculated, 38.4% expected AKI incidence). Data analysis will examine if positive/negative balances predict AKI incidence, severity, RRT need, ICU stay, and 28-day mortality, using AKI-FB risk score. No interventions; standard care only.
- Keywords
- Fluid Balance, acute kidney injury, AKI, critically ill, KDIGO criteria
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Kidney Injury (AKI)
Development of AKI defined by KDIGO criteria (increase in serum creatinine by ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days, or urine output <0.5 mL/kg/h for 6 hours).
Measured: Within 7 days after ICU admission
Secondary outcomes (1)
AKI Stage by KDIGO Criteria
Worst stage of AKI (Stage 1: SCr 1.5-2.9x baseline or UO <0.5 mL/kg/h ≥6h; Stage 2: SCr 3-5.9x or UO <0.5 mL/kg/h ≥12h; Stage 3: SCr ≥6x or ≥4.0 mg/dL or RIFLE F/ESRD, UO <0.3 mL/kg/h ≥24h or anuria ≥12h).
Measured: Within 7 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid BalanceStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Bassam Gayel Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338734
- Sponsor's protocol ID
- Fluid Balance in AKI
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Balance During Early Hours of Acute Kidney Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07338734
- Acronym / sponsor ID
- Fluid Balance in AKI
- Keywords
- Fluid Balance, acute kidney injury, AKI, critically ill, KDIGO criteria
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational cohort study evaluates if fluid balance in the first 48 hours of ICU admission is linked to acute kidney injury (AKI) in critically ill adults. Patients without AKI at entry will have fluids tracked hourly via charts, weights, and labs to assess AKI risk by KDIGO criteria within 7 days. Findings may guide better fluid management to lower AKI rates.
Detailed description
This prospective observational cohort study at Assiut University Hospital ICU investigates the association between fluid balance in the first 48 hours of admission and acute kidney injury (AKI) development. Critically ill adults (≥18 years) without AKI at baseline will undergo routine monitoring: hourly fluid intake/output (IV fluids, blood products, urine, drains, insensible losses), daily weights, serial labs (SCr, BUN, electrolytes, albumin, CRP), and clinical/hemodynamic assessments. AKI is defined/staged by KDIGO criteria within 7 days. Sample size is 120 (Epi-Info calculated, 38.4% expected AKI incidence). Data analysis will examine if positive/negative balances predict AKI incidence, severity, RRT need, ICU stay, and 28-day mortality, using AKI-FB risk score. No interventions; standard care only.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older admitted to the intensive care unit (ICU) at Assiut University Hospital without acute kidney injury (AKI) at admission. Eligible cases include prerenal, renal, postrenal AKI with hypovolemia; postoperative; CKD up to stage IIIb; compensated heart failure needing fluids.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older admitted to the ICU.
- Patients with no AKI at ICU admission.
- AKI secondary to (prerenal cause-renal and post renal with manifestation of hypovolemia)-postoperative settings-On top of CKD up to Stage 111b-Compansated heart failure with indication of fluid therapy
Key exclusion criteria (5 listed)
- Patients with pre-existing end-stage renal disease requiring dialysis.
- Patients with known chronic kidney disease stage 4 or higher.
- ICU readmissions during the same hospitalization.
- Patients who received renal replacement therapy before ICU admission
- Patients with AKI with manifestation of over load as pulmonary edema- pulmonary embolism-Acute decompensated heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Acute Kidney Injury (AKI)
Time frame: Within 7 days after ICU admission
Development of AKI defined by KDIGO criteria (increase in serum creatinine by ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days, or urine output <0.5 mL/kg/h for 6 hours).
1 secondary outcome
AKI Stage by KDIGO Criteria
Time frame: Within 7 days after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Balance and Acute Kidney Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Kidney Injury (AKI) (time frame: Within 7 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.