CClinicalTrials.gg
Not yet recruitingNCT07452484Updated Mar 5, 2026

SII in AKI With Cirrhosis

An observational study in AKI in Cirrhosis, sponsored by Sohag University. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
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Study summary

Acute Kidney Injury (AKI) is a common and serious complication in patients withAcute Kidney Injury (AKI) is a common and serious complication in patients with liver cirrhosis, affecting up to 20-50% of hospitalized cirrhotics and contributing significantly to morbidity and mortality. The pathophysiology is complex and includes Prerenal AKI due to hypovolemia, Hepatorenal Syndrome-AKI (HRS-AKI) resulting from systemic and renal vasoconstriction, and Acute Tubular Necrosis (ATN) from ischemic or nephrotoxic insults . Accurate differentiation between these etiologies is critical, as each requires a distinct management strategy-volume expansion for prerenal AKI, vasoconstrictors for HRS-AKI, and supportive care or renal replacement therapy for ATN . Early recognition of AKI subtype is therefore essential to improve patient outcoment out Serum creatinine (sCr) is the conventional biomarker for AKI diagnosis and staging. However, in cirrhotic patients, sCr is often unreliable due to reduced hepatic creatinine production, decreased skeletal muscle mass (sarcopenia), and fluid overload While previous studies have reported SII at single time points, serial SII measurements provide dynamic insight into the evolution of systemic inflammation and kidney injury. In cirrhotic patients, fluctuations in SII over the first 24-72 hours may detect AKI earlier than sCr, differentiate between etiologies (Prerenal, HRS-AKI, ATN), and predict in-hospital mortality . This approach is particularly valuable in cirrhosis, where traditional markers are unreliable, and could inform timely interventions and risk stratification, representing a novel application of a readily available laboratory index in a high-risk population.

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Conditions studied

  • AKI in Cirrhosis
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In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who develop AKI on top Liver cirrhosis

Inclusion criteria

  • a) Age ≥18 years

    b) Confirmed liver cirrhosis (Section 5)

    c) Hospital admission for acute decompensation or evaluation

Exclusion criteria

Exclusion Criteria:

  • a) ESRD or dialysis dependence.

    b) Kidney transplant recipient.

    c) Pregnancy.

    d) Active malignancy other than HCC.

    e) Massive GI bleeding within 5 days.

    f) Use of nephrotoxic drugs within 7 days (NSAIDs, aminoglycosides, amphotericin, contrast media, chemotherapy ).

    g) Obstructive uropathy .

    h) Active infection at admission (per infection rule-out protocol).

    i) Hematologic disorders affecting CBC (e.g., leukemia, aplastic anemia).

    j) Failure to obtain informed consent.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observitional cohort study

    Diagnostic Test: No intervention needed · Other: SII · Diagnostic Test: Serial systemic immune inflammation index

Interventions

  • Diagnostic testNo intervention needed

    No intervention needed

  • OtherSII

    Serial systemic immune inflammation index

  • Diagnostic testSerial systemic immune inflammation index

    SII= platelets ×Neutrophils ÷lymphocytes

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What researchers measure

Primary outcomes

  1. SII measurements

    Time frame: 6 months

  2. To compare peak SII between cirrhosis with AKI vs cirrhosis without AKI.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07452484
Lead sponsor
Sohag University
Responsible party
Salma Ahmed Fathy (Resident doctor, Sohag University) — Principal investigator
First posted
Mar 5, 2026
Start date
Mar 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

Salma Ahmed Fathy Abdu, Resident doctor
Contact
salmaahmed15299@gmail.com
01095173942 ext. 01124409602
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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