- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05119361
Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. (Early Dry)
Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.
Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.
We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Bron, Francia
- Hôpital Cardiologique Louis Pradel - HCL
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- - Age ≥ 18 ans
- Acute kidney injury with continuous renal replacement therapy
- Fluid overload > 5%
- Equivalent Norepinephrine dose < 0,5 µg/kg/min
Exclusion Criteria:
- - Chronic intermittent haemodialysis
- Active bleeding
- Stroke with coma
- Pregnancy
- advanced directives to withhold or withdraw life-sustaining treatment
- patient's opposition to the use of his/her personal health data."
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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before protocol implementation
A control group reflecting usual practice about net ultrafiltration and deresuscitation strategy in patients with continuous renal replacement therapy in our Department. All patients meeting eligibility criteria between 01/01/2020 and 31/12/2021 will be include. |
After meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input. If the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized. If the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h. Ultrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema. The haemodynamic status is reevaluated all six hours. |
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after protocol implementation
All patients treated by our deresuscitation protocol between 15/02/2020 and 15/08/2021 will be included.
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After meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input. If the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized. If the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h. Ultrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema. The haemodynamic status is reevaluated all six hours. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Computed cumulative fluid balance (mL) at day 5 after protocol onset.
Lasso di tempo: Day 5 after protocol onset.
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Cumulative between input and output, defined as follow:
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Day 5 after protocol onset.
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Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 454
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