NCT07338734

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Feb 2027

Study Start

First participant enrolled

January 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 4, 2026

Last Update Submit

January 4, 2026

Conditions

Keywords

Fluid Balanceacute kidney injuryAKIcritically illKDIGO criteria

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • AKI Stage by KDIGO Criteria

    Within 7 days after ICU admission

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Internal Medicine Department, Assiut University

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 14, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01