NCT01515397

Brief Summary

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

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

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

January 2, 2012

Last Update Submit

November 26, 2013

Conditions

Hypovolemia

Outcome Measures

Primary Outcomes (2)

  • base excess [mmol/l]

    Change from baseline at end of surgery, an expected average of 2 hours surgery

  • chloride [mmol/l]

    Change from baseline at end of surgery, an expected average of 2 hours surgery

Secondary Outcomes (6)

  • arterial blood gase analyses

    until 12 hours after surgery

  • coagulation status

    until 12 hours after surgery

  • renal function

    until 12 hours after surgery

  • adverse events

    until 12 hours after surgery

  • hemodynamics (systolic and diastolic blood pressure)

    until 12 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

balanced gelatine solution

EXPERIMENTAL

isotonic colloidal volume substitute

Drug: Gelofusine balanced

non-balanced gelatine solution

ACTIVE COMPARATOR

colloidal volume substitute

Drug: Gelofusine 4%

Interventions

Gelofusine balancedDRUG

Gelofusine balanced combined with Sterofundin ISO

balanced gelatine solution
Gelofusine 4%DRUG

Gelofusine 4% combined with NaCl 0.9%

non-balanced gelatine solution

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients \>= 18 years of age and \<= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test.
  • Patients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution).
  • Scheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution
  • Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

You may not qualify if:

  • Patients of ASA-class \> III
  • Known hypersensitivity to gelatine or to any of the constituents of the solution
  • Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery
  • Patients on hemodialysis
  • Patients suffering from decompensated renal function (i.e. serum creatinine \> 3.0 mg/dl)
  • Patients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) \> 150 mmol/L) Hyperchloremia (serum(Cl-) \> 110 mmol/L)
  • Estimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA)
  • Lactation period
  • Simultaneous participation in another clinical trial
  • Emergencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Aachen, Klinik für Anästhesiologie

Aachen, 52074, Germany

Location

Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main

Frankfurt am Main, 60590, Germany

Location

Related Publications (1)

  • Marx G, Meybohm P, Schuerholz T, Lotz G, Ledinko M, Schindler AW, Rossaint R, Zacharowski K. Impact of a new balanced gelatine on electrolytes and pH in the perioperative care. PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019.

    PMID: 31034525DERIVED

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gernot Marx, Prof. Dr. med.

    Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 24, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

DE(2)