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OpenTrials
Completed

NCT Number: NCT03780686

Dopamine and Norepinephrine Infusion With Restricted Hydration

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11233, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Norepinephrine, dopamine

Drug

drugs to decrease bleeding

Primary outcomes

  1. Changes in serum lactate level

    Time frame: Before induction of anesthesia and up to 12 hours after.

    Serum lactate level in mmol/l

  2. Changes in renal function test

    Time frame: Before induction of anesthesia and up to 12 hours after.

    Measuring creatinine level

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.