Acute Kidney InjuryNCT07529990
Impact of Sodium Profiling During Haemodialysis on Haemodynamic Tolerance and Sonographic Extravascular Lung Water in Shocked Patients With Acute Kidney Injury
An observational study of Acute Kidney Injury and Shock, run by Fayoum University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Shock
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 5 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- • 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).
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Kidney Injury, Shock
- Keywords
- Sodium Profiling, Acute Kidney Injury (AKI), Shock, Lung ultrasound, Hemodialysis
- Medical subject headings
- Acute Kidney Injury, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure (MAP) changes during the session
MAP is asessed pre dialysis, during dialysis and post dialysis to detect changes among the groups
Measured: 2 to 3 hours
Vasopressor Requirement during the session
Vasopressor dose changes during the session among the groups
Measured: 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.
Measured: 4 to 6 hours
Ultrasonagraphic IVC Diameter
Changes in Ultrasonagraphic IVC Diameter pre and post-dialysis among the groups
Measured: 4 to 6 hours
Ultrasonagraphic IVC Collapsibility
Changes in Ultrasonagraphic IVC Collapsibility pre and post-dialysis among the groups
Measured: 4 to 6 hours
Secondary outcomes (4)
Dialysis Completion Rate
the ability to complete the session without haemodynamic instability
Measured: 2 to 3 hours
Length of ICU Stay
Length of ICU Stay among the groups
Measured: 4 to 15 days
Mortality
short term Mortality during ICU stay
Measured: 4 to 15 days
Laboratory findings
Changes in serum sodium, Potassium, blood gases, urea and creatinine pre and post-dialysis among the groups
Measured: 6 to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jan 2024
- Primary completion15 Jun 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Ahmed Abdelkawy, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529990
- Sponsor's protocol ID
- M 690
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sodium Profiling During Haemodialysis on Haemodynamic Tolerance and Sonographic Extravascular Lung Water in Shocked Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07529990
- Acronym / sponsor ID
- M 690
- Conditions
- Acute Kidney Injury, Shock
- Keywords
- Sodium Profiling, Acute Kidney Injury (AKI), Shock, Lung ultrasound, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- • Adult Patients (18 years or older) who are admitted in ICU.
Key exclusion criteria (4 listed)
- • Patients with hemodynamic instability who are not responsive to vasopressors and not candidate for intermittent hemodialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Vasopressor Requirement during the session
Time frame: 2 to 3 hours
Vasopressor dose changes during the session among the groups
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.
Ultrasonagraphic IVC Diameter
Time frame: 4 to 6 hours
Changes in Ultrasonagraphic IVC Diameter pre and post-dialysis among the groups
Ultrasonagraphic IVC Collapsibility
Time frame: 4 to 6 hours
Changes in Ultrasonagraphic IVC Collapsibility pre and post-dialysis among the groups
4 secondary outcomes
Dialysis Completion Rate
Time frame: 2 to 3 hours
Length of ICU Stay
Time frame: 4 to 15 days
Mortality
Time frame: 4 to 15 days
Laboratory findings
Time frame: 6 to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Shock, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (MAP) changes during the session (time frame: 2 to 3 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.