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Patients with pleural effusion with an underlying aetiology of heart failure

Patients with pleural effusion with an underlying aetiology of fluid overload excluding heart failure

Patients with pleural effusion due to exudative, or non-fluid overload causes

Christopher Chan, MBChB

Ken KP Chan, MBChB

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Objective: To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Hypothesis to be tested: The PF NTproBNP levels are superior to existing methods including Light's criteria, serum/pleural fluid (S/PF) protein gradient, and albumin gradient, in identifying transudates and distinguishing between HF- and non-HF-associated PE.

Design and subjects: A prospective case-control study involving patients with PE requiring thoracentesis, caused by hypervolaemia due to HF, diseases other than HF, and patients with pleural effusion without hypervolaemia. Patient characteristics, PF results and effusion aetiology will be analysed. Patient outcomes will be followed up to 3 months to confirm the aetiology of PE. Clinical management of patients will not be affected.

Study instruments: PF of recruited patients will be analysed for albumin, protein, lactate dehydrogenase (LDH) levels and NTproBNP. The diagnosis of HF will be based on clinical features, serum NTproBNP and echocardiogram.

Main outcome measures: The performance of PF NTproBNP level in identifying HF-associated PE.

Data analysis: The PF NTproBNP level will be compared between effusions of different aetiologies. The optimal pleural fluid NTproBNP level with largest area under the receiver operating characteristic curve in identifying HF-associated PE will be determined. Performance of PF NTproBNP level in identifying HF-associated PE, and other biochemical criteria in identifying transudates will be compared. Echocardiographic findings will be correlated with the PF NTproBNP levels.

Expected results: The diagnostic performance of PF NTproBNP will be significantly better in identifying HF-associated effusion than other biochemical criteria.

Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis

Comparing N-terminal-proB-type Natriuretic Peptide With Other Diagnostic Criteria in Discriminating Heart Failure-associated From Non-heart Failure-associated Pleural Effusions

Given patient data and privacy concerns, clinical data involving individual patients will not be shared. Data summary tables may later be published along with the research manuscript, and may be shared upon receipt of a reasonable request.

Pleural fluid NTproBNP will be measured in patients with pleural effusion of various aetiologies including malignancy, pleural infection, heart failure and other causes of volume overload. The sensitivity and specificity of an elevated pleural fluid NTproBNP level in successfully identifying a pleural effusion due to underlying heart failure will be measured and compared against existing classification criteria for pleural effusion such as Light's Criteria, pleural-serum protein gradient or albumin gradient.

Clinical data of patients admitted to the hospital with pleural effusion will be measured and recorded. Statistical analysis will then be performed to evaluate for degree of correlation between the presence or severity of a clinical parameter, echocardiogram results e.g. severe valvular stenosis, or, e.g. presence of medical comorbidities or presence of concomitant infection, and the levels of NTproBNP identified in the patient's pleural fluid detected within same admission.

Roche Diagnostics GmbH

Chinese University of Hong Kong

Honorary Clinical Tutor

Postoperative Complications

Pharmaceutical Solutions

All Drugs and Chemicals

The fluid in group Goal-directed fluid therapy will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system.

The fluid in group Conventional fluid therapy will be administered based on the principle crystalloid solution: colloid solution =2-3:1. The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient.

Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

Applying goal-directed fluid therapy by continuous hemodynamic monitoring system

Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.

Conventional fluid therapy

Yuguang Huang, MD

This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost.

This is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. The details are described as follow.

The study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in Peking Union Medical College Hospital. The study included two stages.

In the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. All the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. Specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. It is a standard procedure in Peking Union Medical College Hospital. Then, the incidence of postoperative complications of each group will be recorded. In addition, sample size will be estimated based on above study's results (estimated 100 participants).

In the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. The incidence of postoperative complications of each group will be recorded.

Goal-directed Intraoperative Fluid Therapy in High-risk Surgery

Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery

the incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting，postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine （N Engl J Med. 2009 Oct 1;361:1368-75）

the length of stay in hospital，from the hospitalized date to the leave date

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis	NCT05797649	Pleural Effusio... Heart Failure Malignant Neopl... Fluid Overload Hypoalbuminemia Renal Failure Cirrhosis Infections		18 Years -	Chinese University of Hong Kong
Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis	NCT05797649	Pleural Effusio... Heart Failure Malignant Neopl... Fluid Overload Hypoalbuminemia Renal Failure Cirrhosis Infections		18 Years -	Chinese University of Hong Kong
Goal-directed Intraoperative Fluid Therapy in High-risk Surgery	NCT02470221	Postoperative C... Fluid Overload	Applying goal-d... Conventional fl...	18 Years - 90 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for fluid overload