Venous Congestion and Organ Dysfunction.

Organ Dysfunction Syndrome Clinical Trial

— CoDoRéa  

Official title:

Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680728
• Other study ID #: GUINOT 2020
• Status: Completed
• Start date: October 6, 2020
• Est. completion date: November 14, 2022

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 14, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hyperemia
• Organ Dysfunction Syndrome
• Venous Congestion

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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