Fluid optimization in urgent abdominal surgery

GDT in Urgent Abdominal Surgery - A Clinical Randomized Trial - GAS-ART

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000563-14-DK

Enrollment

310

Registered

2015-05-18

Start date

2015-07-22

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perforated intestinal diseases and obstructive bowel diseases with an urgent need for surgery. MedDRA version: 20.0 Level: LLT Classification code 10000663 Term: Acute anaphylactic reaction System Organ Class: 100000023018 MedDRA version: 20.0 Level: LLT Classification code 10020680 Term: Hypernatremia System Organ Class: 10000001955

Interventions

Product Name: Human Albumin 5% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Albumin in saline CAS Number: 9048-46-8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A need for urgent abdominal surgery due to radiological verified perforation of the intestine or obstructive bowel disease. The presence of a doctor capable of conducting the peroperative goal directed fluid therapy is mandatory. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: ASA 5 (American Society of Anaesthesiologists classification of physical health score) Intraabdominal surgery within the last 30 days. Dialysis on a regular basis. Patients unable to give informed consent for any reason. Children (age yonger than 18 years) and pregnant women.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if peroperative goal directed fluid therapy and postoperative zero balance fluid therapy can improve postoperative morbidity and mortality compared to standard fluid therapy. ; Secondary Objective: To investigate if the fluid therapy given as mentioned in the primary objective influences our seconary endpoints. ; Primary end point(s): All cause mortality. Major postoperative complications defined as: Unplanned re-operations Life threatening thrombo-embolic events Life threatening bleeding complications Respiratory insufficiency with a need of mechanical respiratory support Cardiac arrest (survived) Renal failure with a need of dialysis ;Timepoint(s) of evaluation of this end point: Following the 90-days follow up of the last subject including the trial.	—

Measure

Time frame

Main Objective: To investigate if peroperative goal directed fluid therapy and postoperative zero balance fluid therapy can improve postoperative morbidity and mortality compared to standard fluid therapy. ; Secondary Objective: To investigate if the fluid therapy given as mentioned in the primary objective influences our seconary endpoints. ; Primary end point(s): All cause mortality. Major postoperative complications defined as: Unplanned re-operations Life threatening thrombo-embolic events Life threatening bleeding complications Respiratory insufficiency with a need of mechanical respiratory support Cardiac arrest (survived) Renal failure with a need of dialysis ;Timepoint(s) of evaluation of this end point: Following the 90-days follow up of the last subject including the trial.

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Secondary

Measure	Time frame
Secondary end point(s): Minor postoperative complications, including: Superficial wound complications, peritonitis, paralysis of intestine, pneumonia, cystitis, atrial arrhythmias, pleural effusion, pulmonary edema, deep venous thrombosis, delirium. Time in the OR Time in the recovery room Time in the Intensive care unit Total Length Of Stay (LOS). Time to death. Time with mechanical respiratory support. ;Timepoint(s) of evaluation of this end point: Following the 90-days follow up of the last subject included in the trial.	—

Measure

Time frame

Secondary end point(s): Minor postoperative complications, including: Superficial wound complications, peritonitis, paralysis of intestine, pneumonia, cystitis, atrial arrhythmias, pleural effusion, pulmonary edema, deep venous thrombosis, delirium. Time in the OR Time in the recovery room Time in the Intensive care unit Total Length Of Stay (LOS). Time to death. Time with mechanical respiratory support. ;Timepoint(s) of evaluation of this end point: Following the 90-days follow up of the last subject included in the trial.

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Countries

Denmark

Contacts

Public ContactSurgical department, att. GAS-ART

Holbaek Sygehus, Research unit

bbrn@regionsjaelland.dk+45594840004344

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 23, 2026