CoDoRĂ©a: Venous Congestion and Organ Dysfunction.

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04680728
Collaborator
(none)
305
1
24.8
12.3

Study Details

Study Description

Brief Summary

Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.

Condition or Disease Intervention/Treatment Phase
  • Other: collection of biological parameters
  • Other: collection of echographic parameters
  • Other: collection of clinical parameters

Study Design

Study Type:
Observational
Anticipated Enrollment :
305 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.
Actual Study Start Date :
Oct 6, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
patient

Patient admitted to intensive care for less than 24 hours.

Other: collection of biological parameters
haemoglobin, haematocrit, sodium, chloraemia, total protein, albumin, L-lactate, pro-BNP, creatinine, uremia, AST, ALT, GGT, ALP, bilirubin, prothrombin time, urinary test if available.

Other: collection of echographic parameters
echocardiography (FEVG, subaortic ITV before and after LJP, cardiac index, MAPSE, mitral flow doppler, RVFAC, FEVD, STDVD, VD/VG ratio, TAPSE, tricuspid S wave, IT with PAPs, tricuspid flow doppler), Doppler of suprahepatic veins (S wave, D wave, S/D ratio), renal doppler (VII, RRI, aspect of venous flow in cortical and hilar), femoral venous doppler, doppler of the portal trunk, diameter of the VCI.

Other: collection of clinical parameters
eason for hospitalisation, co-morbidities, IGS2 score, SOFA, haemodynamic signs (BP, HR, CVP), sinus rhythm or not, temperature, diuresis, weight, input-output assessment, use of dialysis, ventilatory parameters (intubation, mode, FiO2(%), Vt, FR, PEEP, plateau pressure, driving pressure), state of shock (sepsis, postoperative, haemorrhagic, cardiogenic), transfusion (type, number), catecholamines (type, dose, duration), diuretics and dose, clinical criteria of venous congestion (jugular turgidity, hepato-jugular reflux, hepatosplenomegaly, pitting oedemas of the lower limbs, hepatalgia), neurological evaluation (Glasgow Coma Scale, CAM-ICU), time to resume enteral feeding and bowel movements, weight.

Outcome Measures

Primary Outcome Measures

  1. the presence of venous congestion [From date of inclusion until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 28 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult

  • Patient who has expressed his or her non-opposition to the collection of data (or the health care proxy, or a close relative if the patien is unable to receive the information)

  • Patient admitted to intensive care for less than 24 hours.

Exclusion Criteria:
  • Person not affiliated to the national health insurance

  • Minor, protected major

  • Pregnant or breastfeeding women

  • Anechogenicity confirmed by the operator

  • Chronic atrial fibrillation

  • Mechanical cardiac assistance

  • Uncontrolled blood pressure (MAP < 65 mmHg)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04680728
Other Study ID Numbers:
  • GUINOT 2020
First Posted:
Dec 23, 2020
Last Update Posted:
Dec 23, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 23, 2020