NCT07842562

Brief Summary

The goal of this retrospective observational study is to evaluate how long continuous renal replacement therapy (CRRT) circuits remain in use in adult intensive care unit patients and to describe how CRRT pressure measurements change over time. The main questions it aims to answer are: Are higher maximum and mean transmembrane pressure (TMP) values associated with longer CRRT circuit lifespan? Do time-normalized pressure trajectories and cumulative TMP burden differ between circuits with different lifespans? Do access pressure patterns influence the relationship between pressure measurements and circuit lifespan? Researchers will analyze archived CRRT device log files, including access pressure, filter pressure, effluent pressure, return pressure, and TMP measurements. No additional procedures, interventions, or study visits will be required. No directly identifiable patient information will be included in the analytical dataset.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

September 21, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Continuous Renal Replacement TherapyContinuous Kidney Replacement TherapyCRRT Circuit LifespanTransmembrane PressureCircuit Pressure Dynamics

Outcome Measures

Primary Outcomes (1)

  • Maximum Transmembrane Pressure Across CRRT Circuit Lifespan Categories

    To compare maximum transmembrane pressure values among CRRT sessions grouped by circuit lifespan: less than 12 hours, 12 to less than 24 hours, 24 to less than 48 hours, and 48 hours or longer.

    From the first to the last valid pressure recording of each CRRT session

Secondary Outcomes (1)

  • Initial 6-hour TMP slope

    During the first 6 hours of each CRRT session

Study Arms (4)

CRRT Circuit Lifespan <12 Hours

CRRT sessions with a circuit lifespan of less than 12 hours, defined as the time between the first and last valid pressure recording in the device log. No intervention was assigned.

Other: Archived CRRT Device Log Data

CRRT Circuit Lifespan 12 to <24 Hours

CRRT sessions with a circuit lifespan of at least 12 hours but less than 24 hours, defined as the time between the first and last valid pressure recording in the device log. No intervention was assigned.

Other: Archived CRRT Device Log Data

CRRT Circuit Lifespan 24 to <48 Hours

CRRT sessions with a circuit lifespan of at least 24 hours but less than 48 hours, defined as the time between the first and last valid pressure recording in the device log. No intervention was assigned.

Other: Archived CRRT Device Log Data

CRRT Circuit Lifespan ≥48 Hours

CRRT sessions with a circuit lifespan of 48 hours or longer, defined as the time between the first and last valid pressure recording in the device log. No intervention was assigned.

Other: Archived CRRT Device Log Data

Interventions

This observational study involves no assigned intervention, treatment, device use, or change in clinical care. The study analyzes archived pressure recordings from CRRT device log files generated during routine clinical care. The analyzed variables include access pressure, filter pressure, effluent pressure, return pressure, and transmembrane pressure. CRRT circuit lifespan is evaluated retrospectively according to the time between the first and last valid pressure recording. No additional procedures or study-related interventions are performed.

CRRT Circuit Lifespan 12 to <24 HoursCRRT Circuit Lifespan 24 to <48 HoursCRRT Circuit Lifespan <12 HoursCRRT Circuit Lifespan ≥48 Hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult intensive care unit (ICU) patients who underwent continuous renal replacement therapy (CRRT) using the Prismaflex platform. Archived device log files (LOX format) generated during routine clinical care were evaluated. The unit of analysis was the individual CRRT session rather than the patient, as device logs were structured at the treatment-session level and patient-level linkage was not consistently available. Eligible sessions had a minimum runtime of 1 hour and at least 60 valid, chronologically ordered pressure recordings.

You may qualify if:

  • Archived CRRT treatment sessions performed in adult intensive care unit patients.
  • CRRT sessions recorded on the Prismaflex platform and available as LOX device log files.
  • Sessions with a circuit lifespan of at least 1 hour, defined as the time between the first and last valid pressure recording.
  • Sessions containing sufficient time-stamped pressure data for analysis, including at least 60 valid pressure measurements.
  • Sessions with available pressure recordings for the relevant variables, including transmembrane pressure, access pressure, filter pressure, effluent pressure, and/or return pressure.
  • Sessions with adequate data integrity and chronologically interpretable pressure records.

You may not qualify if:

  • CRRT sessions with a runtime of less than 1 hour.
  • Sessions with missing pressure tables.
  • Sessions with fewer than 60 pressure measurements.
  • Sessions with missing or incomplete primary device records.
  • Sessions with missing timestamps or pressure records that cannot be ordered chronologically.
  • Sessions with inadequate pressure-data density for trajectory analysis.
  • Sessions with major data-integrity problems that prevent reliable calculation of circuit lifespan or pressure-derived variables.
  • Duplicate or otherwise unusable device-log records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital

Yenimahalle, Ankara, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical IllnessAcute Kidney Injury

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiology specialist, M.D.

Study Record Dates

First Submitted

September 21, 2026

First Posted

September 25, 2026

Study Start

September 20, 2026

Primary Completion

September 20, 2026

Study Completion

September 21, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers. This retrospective study uses archived CRRT device log files, and patient-level linkage was not consistently available. The analytical dataset does not include directly identifiable patient information; however, the underlying device logs and study dataset will not be made publicly available because of institutional data-protection requirements and the terms of the ethics approval. Aggregate results will be reported in the publication.

Locations