CClinicalTrials.gg
CompletedNCT07529990Updated Jun 4, 2026

Impact of Sodium Profiling During Haemodialysis on Haemodynamic Tolerance and Sonographic Extravascular Lung Water in Shocked Patients With Acute Kidney Injury

An observational study in Acute Kidney Injury and Shock, sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Fayoum University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

A study conducted to evaluate the effects of sodium profiling haemodialysis compared with conventional haemodialysis on hemodynamic tolerance and extravascular lung water in critically ill patients with AKI and shock.

Read the detailed description

A prospective comparative study was conducted on 120 ICU patients with AKI and shock and indicated for acute intermittent hemodialysis, divided into three groups of 40 patients each: Group 1: conventional hemodialysis, Group 2: linear sodium profiling, and Group 3: stepwise sodium profiling. Hemodynamic parameters, vasopressor requirements, lung ultrasound scores, and IVC measurements were assessed before, during, and after dialysis to evaluate the effects of sodium profiling haemodialysis compared with conventional haemodialysis on hemodynamic tolerance and extravascular lung water in critically ill patients with AKI and shock.

02

Conditions studied

  • Acute Kidney Injury
  • Shock

Keywords

  • Sodium Profiling
  • Acute Kidney Injury (AKI)
  • Shock
  • Lung ultrasound
  • Hemodialysis
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 120 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with AKI and shock and indicated for acute intermittent hemodialysis that need vasopressor to maintain their mean blood pressure above 65 mmHg for ≥1-2 h before initiation of HD.

Inclusion criteria

    • Adult Patients (18 years or older) who are admitted in ICU.

      • AKI (either de novo or superimposed on CKD) as defined by (KDIGO 2023) criteria: an increase in serum creatinine (SCr) by ≥0.3 mg/dL within 48 hours, an increase in SCr to ≥1.5 times baseline within the prior 7 days, or a urine output of \<0.5 mL/kg/h for 6 hours.
      • Hemodynamic instability and they need vasopressor to maintain their mean blood pressure above 65 mmHg for ≥1-2 h before initiation of HD.
      • Indicated for intermittent acute hemodialysis (IHD) per treating team (e.g., refractory hyperkalemia, severe acidosis, uremic complications, or fluid overload).

Exclusion criteria

Exclusion Criteria:

    • Patients with hemodynamic instability who are not responsive to vasopressors and not candidate for intermittent hemodialysis.

      • ESRD on regular HD.
      • Patient judged unsafe for IHD as Severe uncontrolled arrhythmia, active myocardial ischemia active intracranial pathology at risk from osmotic/sodium shifts.
      • Severe dysnatremia: serum Na ≤125 or ≥150 mmol/L.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Conventional Haemodialysis

    conventional IHD group with fixed dialysate sodium of 140 mEq/L

  • Stepwise Sodium Profiling

    stepwise sodium profiling group in which dialysate sodium was reduced in stages (150 → 145 → 140 → 135 mEq/L)

  • Linear Sodium Profiling

    linear sodium profiling group in which dialysate sodium was Initiated at 150 mEq/L, linearly decreased to 135 mEq/L over the course of the dialysis session.

06

What researchers measure

Primary outcomes

  1. Mean Arterial Pressure (MAP) changes during the session

    MAP is asessed pre dialysis, during dialysis and post dialysis to detect changes among the groups

    Time frame: 2 to 3 hours

  2. Vasopressor Requirement during the session

    Vasopressor dose changes during the session among the groups

    Time frame: 2 to 3 hours

  3. Lung Ultrasound Score (LUS)

    Changes in LUS Pre and Post-dialysis among the groups A score of \>15 generally suggests mild congestion, while values \>24 are considered indicative of moderate-to-severe pulmonary oedema or significantly increased EVLW.

    Time frame: 4 to 6 hours

  4. Ultrasonagraphic IVC Diameter

    Changes in Ultrasonagraphic IVC Diameter pre and post-dialysis among the groups

    Time frame: 4 to 6 hours

  5. Ultrasonagraphic IVC Collapsibility

    Changes in Ultrasonagraphic IVC Collapsibility pre and post-dialysis among the groups

    Time frame: 4 to 6 hours

Secondary outcomes

  1. Dialysis Completion Rate

    the ability to complete the session without haemodynamic instability

    Time frame: 2 to 3 hours

  2. Length of ICU Stay

    Length of ICU Stay among the groups

    Time frame: 4 to 15 days

  3. Mortality

    short term Mortality during ICU stay

    Time frame: 4 to 15 days

  4. Laboratory findings

    Changes in serum sodium, Potassium, blood gases, urea and creatinine pre and post-dialysis among the groups

    Time frame: 6 to 12 hours

07

Study locations

1 site
  • Fayoum University
    Al Fayyum, Faiyum Governorate 63611, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07529990
Lead sponsor
Fayoum University
Responsible party
Hisham Ahmed Abdelkawy (Assistant lecture Critical Care Medicine, Fayoum University) — Principal investigator
First posted
Apr 14, 2026
Start date
Jan 1, 2024
Primary completion
Jun 15, 2025
Completion
Jul 5, 2025
Last update
Jun 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion