## Protocol Section
### Identification Module
**NCT ID:** NCT06425289

**Brief Title:** Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy

**Official Title:** Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 69HCL23_5388
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2026-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.

### Conditions Module

**Conditions:**

- Fluid Removal

- Critically Ill

- Continuous Renal Replacement Therapy

- Fluid Overload

**Keywords:**

- Fluid removal

- Hemodynamic

- Net ultrafiltration

- Continuous renal replacement therapy

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Procedure: Fluid balance negativation

During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion .

When the patient's baseline body weight is reached the UF net will be settled to maintain it.

In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it

In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min and without tissue hypoperfusion.

**Intervention Names:**

- Other: Macrohemodynamic parameters

**Label:** Experimental: Corrective strategy

#### Arm Group 2

**Description:** Procedure: Body weight Stabilization

During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance.

In case of weight stabilisation failure (variation \>5%), the UF net can be increased to 1,5 ml/kg/h.

In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min.

**Intervention Names:**

- Other: Macrohemodynamic parameters

**Label:** Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental: Corrective strategy

- Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled

**Description:** Macrohemodynamic parameters will be estimated with transpulmonary thermodilution every 6 hours during the intervention period (5 days).

* Cardiac index
* Extravascular lung water index
* Pulmonary vascular permeability index
* Cardiac function index
* Global end-diastolic volume index
* Central venous pressure
* Fluid responsivness status (passive leg rising test)

**Name:** Macrohemodynamic parameters

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Area under the curve of a cardiac index \< 2.4 L/min/m2 (L/min/m2.hr), determined by transpulmonary thermodilution every 6 hours, with three boli of cold saline in the superior vena cava territory.

**Measure:** Area under the curve of a low cardiac index

**Time Frame:** Every 6 hours between day 0 to day 5 (intervention period)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
* At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or vasopressors administration\>12 hours),
* Cumulative UF net less than 1000ml before inclusion,
* Norepinephrine \< 0,5 µg/kg/min,
* Absence of hypoperfusion signs,
* Fluid overload defined as follows: fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (AKIKI edema scale \> 2).

Exclusion Criteria:

* Chronic renal failure hemodialyzed before admission to the ICU,
* Mechanical circulatory support (ECMO, LVAD),
* Pregnant, child -bearing age or lactating women,
* Stroke less than 30 days,
* Intestinal ischemia less than 7 days documented non-operated,
* Interventional study participation or exclusion period on going,
* Guardianship, curatorship or safeguard of justice,
* Absence of signature of free and informed consent by the patient and/or relative,
* Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
* Absence of transpulmonary thermodilution monitoring

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Critically ill patients with fluid overload and renal replacement therapy for fluid overload, included in EarlyDry trial (NCT05817539) and monitored with transpulmonary thermodilution.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bron

**Contacts:**

***Contact 1:***

- **Name:** RUSTE MARTIN, Dr

- **Role:** CONTACT

**Country:** France

**Facility:** Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon

**Zip:** 69500

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critically Ill

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016638

- Term: Critical Illness

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
