Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT01540916
First received: February 23, 2012
Last updated: February 28, 2012
Last verified: February 2012

February 23, 2012
February 28, 2012
February 2012
February 2013   (final data collection date for primary outcome measure)
Variations in urinary electrolyte concentrations and pH [ Time Frame: From 0 to 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540916 on ClinicalTrials.gov Archive Site
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Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response
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Alterations of acid-base equilibrium are very common in critically ill patients. Thus, understanding their pathophysiology and the possible compensatory mechanisms acting in different organs may play an important role in better set the consequent clinical treatment. The lung and the kidney are the two principal actors of such regulations. Although the respiratory response to acid-base alterations is well understood, less information are available for what the renal system is concerned. Such lack of information is partially due to: 1) the historical consideration of the kidney as a "slow" organ, in response to variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess renal response.

Our group has recently developed a monitoring system aimed at analyzing, in a quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium).

The investigators hypothesize that the renal system reacts to large as well as to minimal variations of the acid-base equilibrium (especially induced by a variation in the respiratory function) in a very fast way, modifying the urinary concentration (and therefore the urinary excretion) of ammonium and some electrolytes (especially chloride).

Primary aim:

To investigate the acute renal response to respiratory alterations of acid-base equilibrium in order to better understand the underlying physiological mechanisms and to evaluate the validity of a renal monitoring system to indirectly assess the effectiveness of the respiratory function.

Secondary aim:

To collect data on the chronic response of the renal system in patients affected by chronic obstructive pulmonary disease (COPD), as well as on the acute response to acute variation of the chronic respiratory acidosis characterizing patients affected by COPD exacerbation.

Study protol:

Mechanically ventilated patients will undergo controlled variation of the ventilatory setting (hyperventilation vs. hypoventilation) in order to induce a controlled reduction or increase in arterial partial pressure of carbon dioxide (and an increase or reduction of arterial pH), within normal range of pH (7.35 - 7.45) During the variations, urinary concentrations of electrolytes and pH will be monitored.

Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Acute Respiratory Variations of Acid-base Equilibrium
  • Other: Increase minute ventilation
    Respiratory rate will be increase in order to have a 30% increase of minute ventilation
  • Other: Decrease minute ventilation
    Respiratory rate will be decrease in order to have a 30% decrease of minute ventilation
  • Experimental: Hyperventilation
    Intervention: Other: Increase minute ventilation
  • Experimental: Hypoventilation
    Intervention: Other: Decrease minute ventilation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Presence of mechanical ventilation
  2. Presence of arterial and central venous line
  3. Presence of urinary catheter

Exclusion Criteria:

  1. acute or chronic renal failure with anuria
  2. presence of continuous renal replacement therapy
  3. hemodynamic instability
  4. less than 16 years of age
Both
16 Years and older
No
Contact: Pietro Caironi, MD +39/02/5503 3230 pietro.caironi@unimi.it
Italy
 
NCT01540916
842
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Not Provided
Not Provided
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP