NCT02033213

Brief Summary

An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 26, 2014

Completed
Last Updated

May 26, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

January 7, 2014

Results QC Date

January 19, 2014

Last Update Submit

April 23, 2014

Conditions

Esophageal Neoplasm

Keywords

intraoperativefluid managementesophageal carcinomasurgerygas exchangetissue perfusion

Outcome Measures

Primary Outcomes (4)

  • Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)

    At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.

    10 minutes, 6 hours

  • Creatinine Values During and After Esophageal Carcinoma Surgery

    At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.

    10 minutes, 6 hours

  • Lactate Values During and After Esophageal Carcinoma Surgery

    At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.

    10 minutes, 6 hours

  • Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.

    At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).

    10 minutes, 6 hours

Secondary Outcomes (2)

  • Duration of Surgery

    End of surgery.

  • Total Volume of Administered Intraoperative Fluid

    End of surgery

Study Arms (2)

Restrictive group

ACTIVE COMPARATOR

Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Other: Restrictive group

Liberal group

ACTIVE COMPARATOR

Patients who received \> 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Other: Liberal group

Interventions

Restrictive groupOTHER

A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery. The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Also known as: Intraoperative restrictive fluid management
Restrictive group
Liberal groupOTHER

A group of patients who received \> 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery. The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.

Also known as: Intraoperative liberal fluid management
Liberal group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • esophageal carcinoma
  • Lewis Tanner procedure (median laparotomy and right thoracotomy)

You may not qualify if:

  • younger than 18 years
  • severe lung disease
  • chronic renal insufficiency
  • a physical status classification \> III on the American Society of Anesthesiologists (ASA) scale
  • impossible to perform epidural catheter placement
  • thoraco-phreno-laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb

Zagreb, City of Zagreb, 10 000, Croatia

Location

Related Publications (1)

  • Karaman Ilic M, Madzarac G, Kogler J, Stancic-Rokotov D, Hodoba N. Intraoperative volume restriction in esophageal cancer surgery: an exploratory randomized clinical trial. Croat Med J. 2015 Jun;56(3):290-6. doi: 10.3325/cmj.2015.56.290.

    PMID: 26088854DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Limitations and Caveats

Small number of participants due to small overall number of patients with esophageal cancer treated in our hospital.

Results Point of Contact

Title
Maja Karaman Ilić, MD PhD
Organization
KBC Zagreb
majakilic1@gmail.com
00385 1 2385 122

Study Officials

  • Maja Karaman Ilić, MD PhD

    Clinical Hospital Centre Zagreb

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 10, 2014

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 26, 2014

Results First Posted

May 26, 2014

Record last verified: 2014-04

Locations

CR(1)