The Efficient PICU Fluid Care Evaluation

NCT06644508 | Not Yet Recruiting

• 1 other identifier: 2023-16717
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate and prevent fluid overload in critically ill, mechanically ventilated children. The main questions it aims to answer are:

1. 1.What is the effect of a restrictive fluid strategy on cumulative fluid balance on day three of invasive mechanical ventilation?
2. 2.What is the feasibility (e.g. adherence to target intake, fluid balance and nutritional goals) of maintaining a neutral fluid balance?

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation; Fluid Overload; Fluid Balance

Keywords

Respiratory Insufficiency; Mechanical ventilation; Fluids; Fluid Balance; Edema; Fluid Overload; Lenght of mechanical ventilation; Childeren; Maintenance fluids

Outcome Measures

Primary Outcomes (1)

• Cumulative fluid balance on day 3 in ml/kg

  Cumulative fluid balance (CFB) over the course of three days after the start of mechanical ventilation is noted in ml/kg. CFB is calculated as a sum of daily (fluid intake \[liters\] - total output \[liters\])/ body weight (kilograms).

  From start mechanical ventilation to 72 hours after start of mechanical ventilation

Secondary Outcomes (28)

• Daily cumulative fluid balance on in ml/kg

  For 10 days, CFB is noted every day at 00:00

• Protein intake in gr/kg/day

  For ten days after start of mechanical ventilation

• Bodyweight in grams

  Bodyweight in grams will be measured at start of mechanical ventilation and at 72 hours after start of mechanical ventilation

• Daily cumulative diuretics dose in mg/kg

  From start of mechnical ventilation for ten days, cumulative diuretic dose will be noted at 00:00

• Blood urea nitrogen (BUN) in mmol/L

  BUN will be measured at 24 hours, 72 hours and at 120 hours after start of mechanical ventilation

Study Arms (2)

Observation of current local practices

NO INTERVENTION

Current local practices regarding fluid management will be observed. Population: Critically ill children receiving mechanical ventilation due to respiratory insufficiency. Patients will be treated according to local protocols at the discretion of the attending physicians.

Strict adherence to european guidelines

ACTIVE COMPARATOR

In this intervention attending physicians will be encouraged to strictly adhere the European (ESPNIC) guidelines regarding fluid management.

Other: Strict adherence to European guidelines

Interventions

Strict adherence to European guidelines OTHER

The goal is to maintain a neutral fluid balance throughout the course of intubation if clinical practice allows. Therefore: * From the start of mechanical ventilation, the maximum maintenance fluids is 65% of the maintenance fluids proposed by the Holliday \& Segar formula. Fluid resuscitation in the first hours after intubation is at the discretion of the attending physician. * Any other interventions to maintain a neutral fluid balance (e.g., starting diuretics, reducing fluid boluses, decreasing creep fluids, or using more concentrated enteral feeding) are at the discretion of the attending physician. * Throughout the intervention, the attending physician decides if clinical practice allows for a decrease in fluid balance, and international feeding goals must always be met.

Strict adherence to european guidelines

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \< 10 years and weight \< 35 kg
• Receiving invasive mechanical ventilation (IMV) due to respiratory failure
• Expected duration of IMV \> 48 hours

You may not qualify if:

• Preterm (\<37weeks gestational age)
• Preexistent (clinical) diagnosis of kidney disease
• Congenital cardiac defect with hemodynamic consequences or reduced cardiac function
• (Ongoing) shock with need for fluid resuscitation and/or vasoactive drugs
• Cardiovascular (including diuretics) drug use on admission (home medication)
• Pre-existent (clinical) diagnosis of liver failure
• Right of left heart failure
• Pulmonary hypertension
• ECMO treatment
• Receiving total parenteral nutrition on admission which won't be stopped
• Failure to include within 12 hours after start of IMV
• Expected duration of IMV \< 48 hours
• Parents or caretakers unable to understand/speak Dutch language
• Surgery \< 48 hours

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (3)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Amsterdam MC

Amsterdam, North Holland, 1100 DD, Netherlands

Location

ErasmusMC

Rotterdam, South Holland, 3015 CN, Netherlands

Location

Related Publications (6)

• Arrahmani I, Ingelse SA, van Woensel JBM, Bem RA, Lemson J. Current Practice of Fluid Maintenance and Replacement Therapy in Mechanically Ventilated Critically Ill Children: A European Survey. Front Pediatr. 2022 Feb 23;10:828637. doi: 10.3389/fped.2022.828637. eCollection 2022.

  PMID: 35281243 BACKGROUND

• Valentine SL, Sapru A, Higgerson RA, Spinella PC, Flori HR, Graham DA, Brett M, Convery M, Christie LM, Karamessinis L, Randolph AG; Pediatric Acute Lung Injury and Sepsis Investigator's (PALISI) Network; Acute Respiratory Distress Syndrome Clinical Research Network (ARDSNet). Fluid balance in critically ill children with acute lung injury. Crit Care Med. 2012 Oct;40(10):2883-9. doi: 10.1097/CCM.0b013e31825bc54d.

  PMID: 22824936 BACKGROUND

• Ingelse SA, Geukers VG, Dijsselhof ME, Lemson J, Bem RA, van Woensel JB. Less Is More?-A Feasibility Study of Fluid Strategy in Critically Ill Children With Acute Respiratory Tract Infection. Front Pediatr. 2019 Dec 10;7:496. doi: 10.3389/fped.2019.00496. eCollection 2019.

  PMID: 31921715 BACKGROUND

• Diaz F, Nunez MJ, Pino P, Erranz B, Cruces P. Implementation of preemptive fluid strategy as a bundle to prevent fluid overload in children with acute respiratory distress syndrome and sepsis. BMC Pediatr. 2018 Jun 26;18(1):207. doi: 10.1186/s12887-018-1188-6.

  PMID: 29945586 BACKGROUND

• Charaya S, Angurana SK, Nallasamy K, Jayashree M. Restricted versus Usual/Liberal Maintenance Fluid Strategy in Mechanically Ventilated Children: An Open-Label Randomized Trial (ReLiSCh Trial). Indian J Pediatr. 2025 Jan;92(1):7-14. doi: 10.1007/s12098-023-04867-4. Epub 2023 Oct 18.

  PMID: 37851328 BACKGROUND

• Brossier DW, Tume LN, Briant AR, Jotterand Chaparro C, Moullet C, Rooze S, Verbruggen SCAT, Marino LV, Alsohime F, Beldjilali S, Chiusolo F, Costa L, Didier C, Ilia S, Joram NL, Kneyber MCJ, Kuhlwein E, Lopez J, Lopez-Herce J, Mayberry HF, Mehmeti F, Mierzewska-Schmidt M, Minambres Rodriguez M, Morice C, Pappachan JV, Porcheret F, Reis Boto L, Schlapbach LJ, Tekguc H, Tziouvas K, Parienti JJ, Goyer I, Valla FV; Metabolism Endocrinology and Nutrition section of the European Society of Pediatric and Neonatal Intensive Care (ESPNIC). ESPNIC clinical practice guidelines: intravenous maintenance fluid therapy in acute and critically ill children- a systematic review and meta-analysis. Intensive Care Med. 2022 Dec;48(12):1691-1708. doi: 10.1007/s00134-022-06882-z. Epub 2022 Oct 26.

  PMID: 36289081 BACKGROUND

MeSH Terms

Conditions

Edema; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Joris Lemson, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joris Lemson, MD PhD

CONTACT

0031243617273; joris.lemson@radboudumc.nl

Michiel Schwerzel, MSc

CONTACT

0031243617273; michiel.schwerzel@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre prospective study (clinical implementation evaluation) with a before-after design with continuous recruitment and single measurements

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From publication until 15 years after publication
• Access Criteria: Data will be made available upon reasonable request to the corresponding author

Locations

NL (3)