## Protocol Section
### Identification Module
**NCT ID:** NCT00732979

**Acronym:** IVC CLAMP

**Brief Title:** Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

**Official Title:** IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** NNR-01
#### Organization
**Class:** OTHER
**Full Name:** Heidelberg University
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-05-17

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Start Date
**Date:** 2008-03

**Status Verified Date:** 2013-05

#### Study First Post Date
**Date:** 2008-08-12
**Type:** ESTIMATED
**Study First Submit Date:** 2008-08-07
**Study First Submit QC Date:** 2008-08-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Heidelberg University

#### Responsible Party

**Investigator Affiliation:** Heidelberg University

**Investigator Full Name:** Nuh Rahbari

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.

In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.

### Conditions Module

**Conditions:**

- Hemorrhage

**Keywords:**

- Elective

- hepatic

- resection

- due to any

- reason.

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 152

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Infrahepatic inferior vena cava clamping The inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards.

**Intervention Names:**

- Procedure: Infrahepatic inferior vena cava clamping

**Label:** A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below \< 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration.

**Intervention Names:**

- Procedure: No infrahepatic inferior vena cava clamping

**Label:** B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**Description:** The inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards.

**Name:** Infrahepatic inferior vena cava clamping

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- B

**Description:** Patients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below \< 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration.

**Name:** No infrahepatic inferior vena cava clamping

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Intraoperative blood loss

**Time Frame:** End of operation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 18 years
* Scheduled for elective hepatic resection due to any reason
* American Society of Anesthesiologists (ASA) score I to III
* Written informed consent

Exclusion Criteria:

* Medical conditions exposing patient at increased risk for not tolerating liver resection:
* Cirrhosis (Child-Pugh B and C)
* (Hereditary) coagulopathy
* Medical conditions exposing patient at increased risk for not tolerating this trial's study interventions:
* Severe heart disease (e.g. severe CAD requiring intervention, NYHA IV)
* Pulmonary hypertension
* Renal insufficiency (serum creatinin \>2mg/dl or \>177µmol/l; conversion factor 88.4 or requiring dialysis)
* Severe hypernatremia (serum sodium \>155mmol/l)
* Severe hyperchloremia
* For female subjects: pregnancy and lactation
* Impaired mental state or language problems
* Participation in other clinical trials or observation period of competing trials interfering with the endpoints of this trial
* Former participation in the clinical trial
* Expected lack of compliance

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Heidelberg

**Country:** Germany

**Facility:** Department of General, Visceral and Transplantation Surgery, University of Heidelberg

**Zip:** 69120

### References Module

#### References

**Citation:** Rahbari NN, Koch M, Zimmermann JB, Elbers H, Bruckner T, Contin P, Reissfelder C, Schmidt T, Weigand MA, Martin E, Buchler MW, Weitz J. Infrahepatic inferior vena cava clamping for reduction of central venous pressure and blood loss during hepatic resection: a randomized controlled trial. Ann Surg. 2011 Jun;253(6):1102-10. doi: 10.1097/SLA.0b013e318214bee5.

**PMID:** 21412143

**Citation:** Rahbari NN, Zimmermann JB, Koch M, Bruckner T, Schmidt T, Elbers H, Reissfelder C, Weigand MA, Buchler MW, Weitz J. IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy--a randomised controlled trial in an interdisciplinary setting. Trials. 2009 Oct 13;10:94. doi: 10.1186/1745-6215-10-94.

**PMID:** 19825186

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

### Condition Browse Module - Meshes

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Coag

- Name: Coagulants

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: T204

- Name: Kava

- Relevance: HIGH

- As Found: Umbilical Cord Blood

### Misc Info Module

- Version Holder: 2024-05-24
