Fluid Balance in Acute Kidney Injury in Critically Ill Pa... | NCT07338734

Studies
Fluid Balance in Acute Kidney Injury in Critically Ill Patients

NCT07338734

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Fluid Balance
Acute Kidney Injury
Critically Ill Acute Kidney Injury
Critically Ill

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2026Estimated

Primary Completion Date

Jan 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Jan 4, 2026

First Submission Date that Met QC Criteria

Jan 4, 2026

First Posted Date

Jan 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2026

Last Update Posted Date

Jan 14, 2026Actual

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	Within 7 days after ICU admission

Secondary Outcomes

Measure	Description	Time Frame
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).	Within 7 days after ICU admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D016638	Critical Illness

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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