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The Goal dIrected perFusion Trial, a multi-center, prospective, randomized, controlled study.

The Goal dIrected perFusion Trial, a multi-center, prospective, randomized, controlled study. - GIFT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42063
Enrollment
100
Registered
2015-04-14
Start date
2015-10-04
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

acute kidney injury renal dysfunction

Interventions

Patients will be randomly allocated to the Control or the GDP group. Randomization will be performed locally at each participating Institution, using computer-generated schemes. The patients in cont

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients Patients undergoing cardiac surgery with expected bypass time of 90 minutes or longer

Exclusion criteria

Exclusion criteria: severe chronic renal failure moderate-severe anemia (hematocriet

Design outcomes

Primary

MeasureTime frame
Incidence of AKI, defined according to the AKIN criteria (9) as: AKI stage 1: peak postoperative serum creatinine > 1.5 x baseline, within the first 48 hours after surgery. AKI stage 2: peak postoperative serum creatinine > 2.0 x baseline, within the first 48 hours after surgery (AKI stage 3 will be incorporated in the AKI stage 2 group). Any AKI: stage 1 or higher Peak serum creatinine: within the first 48 postoperative hours. Diagnosis of AKI must be reached within the first 48 hours after surgery, but staging may require a longer time (up to 7 days after surgery).

Secondary

MeasureTime frame
Length of ICU stay (days) Transfusion (PRCs) rate and amount of PRCs units transfused Major morbidity (according to STS): mechanical ventilation > 48 hours, AKI stage 2, surgical revision, mediastinitis, stroke. Operative (in-hospital) mortality

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)