Selective Plasmofiltration for Abdominal Septic Shock: a Clinical Ctudy

NCT07121647 | Completed DMC

• 2 other identifiers: 31_05_2016_№531.05.2016.5.Pirogov
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Group 1: 34 patients received prolonged hemodiafiltration (CVVHDF) on an emergency basis. Group 2: 35 patients received early isolated CVVHDF. Group 3: 32 patients received early combined extracorporeal detoxification (ECD) (selective plasma filtration \[SPF\] + CVVHDF). A comparative analysis of clinical and laboratory parameters was performed.

Conditions

Selective Plasma Filtration

Keywords

septic shock; interleukin-6; continuous renal replacement therapy; selective plasmofiltration,

Outcome Measures

Primary Outcomes (3)

• analysis of hospital mortality

  Estimation of hospital mortality is by means Fisher's exact test.

  hospital mortality from the moment of randomization (point 0) and then on 2,4,6,8,10,12,14 and 30 days

• length of stay in the ICU

  Length of stay in the ICU was evaluated.

  The duration of staying in the ICU, measured from the moment of randomization (point 0) and then until the moment of transfer to the specialized department on 2,4,6,8,10,12,14 and 30 days

• Length of hospital stay

  Time from arriving to leaving hospital was estimated.

  differences in the duration of hospitalization measured from the moment of randomization (point 0) and then on 2,4,6,8,10,12,14 and 30 days in days of staying in the clinic

Study Arms (3)

Group 1 (n=34)

OTHER

Patients got standard conservative therapy in accordance with the principles of the survive sepsis compain (SSC) in combination with isolated continuous veno-venous hemodiafiltration (cvvhdf), which started in the presence of absolute indications such as acidemia, hyperhydration with pulmonary edema, hyperkalemia).

Procedure: renal replacement therapy.

Group 2 (n=35)

ACTIVE COMPARATOR

Patients got standard conservative therapy accordingly with SSC in combination with early isolated veno-venous hemodiafiltration started with AKI 1 stage KDIGO.

Procedure: early isolated CVVHDF.

Group 3 (n=32)

EXPERIMENTAL

Patients got standard conservative therapy in accordance with SSC in combination with extracorporeal blood purification therapies (EBPT) including a selective plasmafiltration in combination with cvvhdf.

Procedure: combined extracorporeal blood purification therapy

Interventions

renal replacement therapy. PROCEDURE

veno-venous hemodiafiltration for emergency indications (CVVHDF).

Group 1 (n=34)

early isolated CVVHDF. PROCEDURE

early isolated CVVHDF.

Group 2 (n=35)

combined extracorporeal blood purification therapy PROCEDURE

Patients received early combined extracorporeal blood purification therapy (EBPT) (SPF and CVVHDF).

Group 3 (n=32)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Abdominal septic shock (Sepsis-3) and AKI stage 1 according to the KDIGO (Kidney Disease Improving Global Outcomes) classification

You may not qualify if:

• Terminal state, active bleeding, atonic coma, severe heart failure (left ventricular ejection fraction \<25%), decompensated liver failure, body weight less than 20 kg, age under 18 years, pregnancy, as well as cases of septic shock without AKI.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Pirogov Russian National Research Medical University (RNRMU),

Moscow, 117513, Russia

Location

Related Links

• Blood purification in abdominal septic shock with acute kidney injury: a prospective interventional controlled study (part I)
• Blood purification in abdominal septic shock with acute kidney injury: a prospective interventional controlled study (part II)

MeSH Terms

Conditions

Shock, Septic

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The first stage involved standard clinical and laboratory monitoring, along with daily assessment of the severity of the patients' condition. The second stage included the distribution of patients into three groups. The third stage involved the implementation of renal replacement therapy (RRT). The fourth stage consisted of statistical analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care

Model Details: Patients who showed no clinical improvement within 12 hours of admission to the intensive care unit (ICU) (pH ≤ 7.2, lactate ≥ 2.0 mmol/L, base deficit ≤ -2.0 mmol/L) were randomized using a random number generator and divided into three groups: Group 1 (n=34): Patients received standard conservative therapy combined with isolated prolonged veno-venous hemodiafiltration (CVVHDF), which was initiated upon the occurrence of urgent indications for renal replacement therapy (RRT), such as uremia, oliguria, and hyperkalemia. Group 2 (n=35): Patients underwent early isolated CVVHDF. Group 3 (n=32): Patients received early combined extracorporeal blood purification therapy (EBPT) (SPF and CVVHDF).

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: August 13, 2025
• Study Start: September 15, 2016
• Primary Completion: February 20, 2025
• Study Completion: March 3, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 10.03.2025
• Access Criteria: Open access

Locations

RU (1)