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Completed

NCT Number: NCT07529990

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fayoum University

Al Fayyum, Faiyum Governorate, 63611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 2 to 3 hours

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

  2. Vasopressor Requirement during the session

    Time frame: 2 to 3 hours

    Vasopressor dose changes during the session among the groups

  3. Lung Ultrasound Score (LUS)

    Time frame: 4 to 6 hours

    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.

  4. Ultrasonagraphic IVC Diameter

    Time frame: 4 to 6 hours

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

  5. Ultrasonagraphic IVC Collapsibility

    Time frame: 4 to 6 hours

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

Secondary outcomes

  1. Dialysis Completion Rate

    Time frame: 2 to 3 hours

    the ability to complete the session without haemodynamic instability

  2. Length of ICU Stay

    Time frame: 4 to 15 days

    Length of ICU Stay among the groups

  3. Mortality

    Time frame: 4 to 15 days

    short term Mortality during ICU stay

  4. Laboratory findings

    Time frame: 6 to 12 hours

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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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