IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy - a randomised controlled trial in an interdisciplinary setting

Nuh N Rahbari,Markus W Büchler,Johannes B Zimmermann,Markus A Weigand,Moritz Koch,Jürgen Weitz,Thomas Bruckner,Heike Elbers,Thomas Schmidt,Christoph Reissfelder

doi:10.1186/1745-6215-10-94

Abstract

BackgroundIntraoperative haemorrhage is a known predictor for perioperative outcome of patients undergoing hepatic resection. While anaesthesiological lowering of central venous pressure (CVP) by fluid restriction is known to reduce bleeding during transection of the hepatic parenchyma its potential side effects remain poorly investigated. In theory it may have negative effects on kidney function and tissue perfusion and bears the risk to result in severe haemodynamic instability in case of profound intraoperative blood loss. The present randomised controlled trial evaluates efficacy and safety of infrahepatic inferior vena cava (IVC) clamping as an alternative surgical technique to reduce CVP during hepatic resection.Methods/DesignThe proposed IVC CLAMP trial is a single-centre randomised controlled trial with a two-group parallel design. Patients and outcome-assessors are blinded for the treatment intervention. Patients undergoing elective hepatic resection due to any reason are enrolled in IVC CLAMP. All patients admitted to the Department of General-, Visceral-, and Transplant Surgery, University of Heidelberg for elective hepatic resection are consecutively screened for eligibility and written informed consent is obtained on the day before surgery. The primary objective of this trial is to assess and compare the amount of blood loss during hepatic resection in patients receiving surgical CVP reduction by clamping of the IVC as compared to anaesthesiological CVP without infrahepatic IVC clamping reduction. In addition to blood loss a set of general as well as surgical variables are analysed.DiscussionThis is a randomised controlled patient and observer blinded two-group parallel trial designed to assess efficacy and safety of infrahepatic IVC clamping during elective hepatectomy.Trial registrationClinicalTrials NCT00732979

Highlights

Intraoperative haemorrhage is a known predictor for perioperative outcome of patients undergoing hepatic resection
While this study revealed reduced bleeding for those patients who received inferior vena cava (IVC) clamping below the liver and suggested a positive impact of IVC clamping on bleeding and potentially outcome of patients undergoing hepatectomy, it's retrospective, non-randomised study design does not allow for general recommendation of infrahepatic IVC clamping
Reduction of central venous pressure (CVP) as currently performed may have detrimental effects on tissue perfusion and kidney function and may, result in severe haemodynamic instability in case of intraoperative haemorrhage. For this reason the present randomised trial evaluates the technique of selective infrahepatic IVC clamping to lower CVP in patients undergoing hepatectomy without routine use of portal triad clamping and without concomitant anaesthesiological CVP reduction

Summary

Background

The outcome of patients undergoing hepatic resection has markedly improved since the late 1980's [1]. Several non-randomised as well as one randomised trial reported reduction of CVP to result in significantly less intraoperative blood loss [6,7,8] For this reason many surgeons currently prefer to perform hepatic resections after previous CVP reduction below 5 mmHg which is usually achieved by restricted intravenous fluid administration, and - if required - the application of diuretics and nitroglycerine [8]. Reduction of CVP as currently performed may have detrimental effects on tissue perfusion and kidney function and may, result in severe haemodynamic instability in case of intraoperative haemorrhage For this reason the present randomised trial evaluates the technique of selective infrahepatic IVC clamping to lower CVP in patients undergoing hepatectomy without routine use of portal triad clamping and without concomitant anaesthesiological CVP reduction. Patients in the control group are treated according to the current local standards consisting of anaesthesiological CVP reduction primarily achieved via fluid restriction and application of diuretics or nitro-compounds without routine use of any kind of vascular clamping

Methods/design

Discussion

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