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

NCT07529990 | Completed DMC

• 1 other identifier: M 690
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Shock

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Mean Arterial Pressure (MAP) changes during the session

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

  2 to 3 hours

• Vasopressor Requirement during the session

  Vasopressor dose changes during the session among the groups

  2 to 3 hours

• 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.

  4 to 6 hours

• Ultrasonagraphic IVC Diameter

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

  4 to 6 hours

• Ultrasonagraphic IVC Collapsibility

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

  4 to 6 hours

Secondary Outcomes (4)

• Dialysis Completion Rate

  2 to 3 hours

• Length of ICU Stay

  4 to 15 days

• Mortality

  4 to 15 days

• Laboratory findings

  6 to 12 hours

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Faiyum Governorate, 63611, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury; Shock

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture Critical Care Medicine

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: January 1, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 5, 2025
• Last Updated: June 4, 2026

Record last verified: 2023-12

Locations

EG (1)