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Dopamine and Norepinephrine Infusion With Restricted Hydration

NCT ID: NCT03780686

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-09

Study Completion Date

2018-12-15

Brief Summary

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This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.

Detailed Description

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One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).

The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.

Conditions

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Renal Function Test, Urine Output, Lactate Level

Keywords

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Restrictive hydration, Dopamine, Norepinephrine, Serum lactate, Standard hydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dopamine and norepinephrine infusion

Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid

Group Type ACTIVE_COMPARATOR

Norepinephrine, dopamine

Intervention Type DRUG

drugs to decrease bleeding

Norepinephrine

Infusion norepinephrine (3mcg/kg/h) with restricted fluid.

Group Type ACTIVE_COMPARATOR

Norepinephrine, dopamine

Intervention Type DRUG

drugs to decrease bleeding

Standard fluid management

Standard fluid managements.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Norepinephrine, dopamine

drugs to decrease bleeding

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients with American Society of Anesthesiologists (ASA) physical status I or II
* Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study.

Exclusion Criteria

* Patients with coagulopathies,
* Hepatic dysfunction (prothrombin ratio \<50%),
* Renal dysfunction,
* Congestive heart failure (New York Heart Association scores ≥3),
* Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Anis Metry

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASUH3206/17

Identifier Type: -

Identifier Source: org_study_id